Implantable cardiac sensors

ABSTRACT

Embodiments of the present disclosure relate to implantable cardiac sensors. In an exemplary embodiment, a medical system for determining a treatment regimen for a patient, comprises: at least one sensor configured to sense right atrial pressure and left atrial pressure. The medical system further comprises a receiver configured to receive the measurement data corresponding to the sensed right atrial pressure and the sensed left atrial pressure, and output to a display device the received measurement data, wherein the condition is at least one selected from the group of: left heart failure, right heart failure, and primary pulmonary disorder.

FIELD

The present disclosure relates to systems for measuring physiologicparameters, such as blood pressure, and more specifically to systems formeasuring cardiac physiologic parameters.

BACKGROUND

During the past decade, the number of coronary deaths in the UnitedStates has steadily decreased thanks to advancements in medical scienceand treatment, but the relative number of heart failure deaths hasincreased, indicating that more people are living with a high risk ofheart failure than ever before. Generally, heart failure occurs when theheart cannot supply enough blood to the body. As a result, lower volumeoutput leads to a higher filling pressure in the left heart to helpcompensate for the lack of output. Lower volume output also causes lowerorgan perfusion, including a reduction in kidney or renal perfusion.Reduced kidney perfusion can result in a retention of excess fluid. Anacute decompensation episode is when fluid levels rise and/or vascularblood distribution declines to a state that causes the patient toexperience fatigue and dyspnea (trouble breathing), thus presenting tothe hospital. If left untreated, this may result in seriouscomplications and ultimately death.

It has been observed that heart failure primarily initiates as a resultof left-side heart issues. In a normal healthy heart, oxygenated bloodis first carried from the pulmonary veins, through the left atrium, intothe left ventricle, and into the aorta, after which the blood is carriedthroughout the body. Thereafter, deoxygenated blood is carried from thetwo vena cavae into the right atrium, through the right ventricle, andinto the pulmonary arteries, which then carry the blood into the lungsfor oxygenation. The pumping performance of the left ventricle can beaffected by the thickening/thinning of the left ventricular wall or bythe aortic/mitral valve damage, causing less blood to be pumped to therest of the body.

There are at least two categories of heart failures: HFrEF (heartfailure with reduced ejection fraction) and HFpEF (heart failure withpreserved ejection fraction). In HFrEF, the left ventricle fills withenough blood, but cannot pump enough blood out due to poor contractionof the heart muscle. This is also called systolic heart failure. InHFpEF, the heart can pump blood out normally, but the left ventriclefills with less blood due to poor relaxation of the heart musclecreating less blood volume in the ventricle. This is also calleddiastolic heart failure. In either case, there generally is not enoughblood being pumped to the body. Less commonly, biventricular failure canoccur, which is when the left heart cannot pump enough blood out to thebody and the right heart cannot pump enough blood to the lungs.

Pharmacological treatments are commonly employed to reduce heartpressure and prevent acute decompensation episodes. Remotely, theparticular drug used is often determined by a trial and error approachusing sign/symptoms such as weight gain, or by a singular intra-cardiacblood pressure measurement. Medications that are used today to reduceheart pressure and prevent acute decompensation episodes primarilyinclude diuretics and vasodilators (nitrates, hydralazine, aceinhibitors, etc.) while other medications can be beta-blockers,inotropes, and more. Diuretics primarily target excess fluid buildup(fluid retention) and work by making the kidney release more sodium intothe urine. The sodium then takes water with it from the bloodstream,thereby decreasing the amount of fluid flowing through the blood vesselsand ultimately reducing intra-cardiac blood pressure. Loop diuretics,which are common in chronic heart failure, are also known to have avasodilator effect on the venous vasculature, causing an increase invenous capacitance. Therefore, diuretics primarily help lower thepreload on the heart by reducing blood volume from circulation.

Vasodilators are medications that open or dilate blood vessels, whichcan include nitrates, hydralazine, ace-inhibitors, and angiotensinreceptor blockers, to name a few. As a result, blood flows more easilythrough the vessels, primarily arterial resistance vessels, and theheart does not need to pump as hard, thereby reducing intra-cardiacblood pressure. Nitrates, for example, are venous dilators at very lowinitial doses, but primarily increasingly affect arterial dilation inmoderate to high doses (typical dosage of heart failure). Unlikediuretics, vasodilator therapy is primarily used to help reduce vascularresistance and afterload on the heart, which enhances stroke volume andcardiac output and leads to secondary decreases in left ventricularpreload and venous pressures resulting in lower left sided fillingpressure. Beta-blockers work to make the heart pump slower, i.e. induceslower heart rate, and with less force, thereby reducing intra-cardiacblood pressure. Inotropes work to increase the strength of ventricularcontraction and therefore increase the heart rate. This medication maybe used in severe cases where extremely poor perfusion exists and aventricular assist device (VAD) or heart transplant is needed.

Remote pulmonary artery pressure monitoring and a correspondingmedication treatment algorithm utilizing guideline medications has beenproven to be effective in reducing hospitalizations due to heartfailure. As shown in FIG. 1A, by monitoring the correct predictivebiomarkers and performing the appropriate early interventions, the riskof hospitalization in a patient is significantly lowered. For example,in the earliest stages preceding a potential hospitalization event,measurement devices that measure an increase in the filling pressure ofthe heart can allow for timely treatment, resulting in a prevention ofthe pending hospitalization. After increased filing pressures occur,when the heart experiences pre-symptomatic congestion, the intrathoracicimpedance changes. Later, other signs like a sudden weight gain,swelling in the feet and ankles, weakness or shortness of breath(dyspnea), and changes in the frequency of urination show that the bodyis retaining fluid. At these points, however, the congestion istypically at a later stage that is dangerously close to a decompensationepisode. Therefore, it is best to treat the earliest indications becauseby the time later symptoms occur prior to a decompensation episodedevelop, it may already be too late as permanent damage may have alreadybeen done to the organs. To date, remote monitoring of cardiac fillingpressure (or suitable surrogates such as Pulmonary Artery Pressure) isthe only method that has led to significant reductions inhospitalizations.

To understand and treat a patient's heart failure, the hospital performsmany acute analyses using various means of measurements. These includenoninvasive measurements as well as invasive ones so that the medicalservice providers can get a better understanding of the patient'sdisease. Noninvasive measurements include: echocardiogram, which is usedto diagnose the disease, monitor blood flow, and visualize changes inphysiology; weight gain, which determines changes in fluid retention;visual inspection of the jugular vein, which determines fluid retentionstatus; blood pressure readings, which estimate the blood flow of thebody; heart rate; electrocardiography (ECG); and oxygen saturation.Invasive measurements include: right heart catheterization and leftheart catheterization.

Right heart catheterization, which is performed using Swan-Ganzcatheterization, can measure the central venous pressure, right atrialpressure (RAP), right ventricular diastolic and systolic pressures,pulmonary arterial diastolic and systolic pressures, and pulmonaryartery wedge pressure (PAWP). Also, this method can measure the oxygenstatus, temperature, and heart rate of the patient, as well as calculatethe cardiac output, systemic vascular resistance, and pulmonary vascularresistance. The right heart catheterization is primarily used to checkpressures, cardiac output, resistance, and fluid status in the heart.Left heart catheterization can measure the left atrial pressure as wellas the left ventricular diastolic and systolic pressures. The rightheart catheter can be left in a patient for a few days while the medicalservice providers attempt to reduce the patient's intracardiac bloodfilling pressure back to acceptable levels using medications. This is aneffective practice in an acute setting. During the ESCAPE clinicaltrial, the use of pressure measurements was determined as a viable meansto improve a patient's overall status in the acute setting, for exampleby targeting a RAP of 8 mm Hg and a PAWP of 15 mm Hg. However, it wasnot an ongoing solution, and therefore did not prevent hospitalizationsbecause the pressures were assumed to change relatively shortly afterleaving the hospital. Therefore, a right heart catheter is primarilyused to guide therapy to reduce symptoms and pressure in the acutesetting.

Current diagnostic approaches can be divided into two broad settings:acute and remote. The acute setting occurs when a patient is assessed atthe hospital using various methods (invasive or noninvasive). The remotesetting corresponds to patient physiological parameters taken remotely,outside the hospital.

In the acute setting, a right heart catheterization may be used to givethe medical service providers information for selecting appropriatemedications. Generally, a right heart catheterization is viewed asuseful for separating effects of volume and vascular resistance (e.g.,by observing both PAWP and right atrial pressures). Medical serviceproviders will look at the absolute values and ratios to distinguishbetween the two issues, particularly in the left heart failure, suchthat they know when fluid is offloaded and are then able to determinethe status of the blood distribution. In current practice, the acutesetting typically allows for more accurate measurement of the heart'shealth because pressure readings from different locations within theheart are taken into consideration simultaneously.

FIG. 1B is illustrative of the implementation of a right heartcatheterization. The measurement device 40 is attached to the end of apulmonary artery catheter 18 which passes through the right atrium 1,the tricuspid valve 7, the right ventricle 2, through the pulmonaryvalve 58, and into the pulmonary artery 16 where the device 40 takesmeasurement of the blood pressure as deoxygenated blood is carried intothe lung 22. Then, fresh air is carried into the lung 22 from thetrachea 23 after which oxygenated blood is carried through the pulmonaryvein 17, the left atrium 3, the mitral valve 6, the left ventricle 4,and the aortic valve 57. The catheter 18 also has a proximal injectionport which injects cold saline bolus 20 into the right atrium, and athermistor 21 located at a distal end of the catheter to measure thetemperature of the blood in the pulmonary artery 16. This method ofmeasurement is known as thermodilution, which measures the blood flowbased on the premise that when the cold saline bolus is added to thecirculating blood, the rate of blood flow is inversely proportional tothe rate of change in blood temperature resulting from the cold salinebolus over time. This provides a measure of cardiac output.

Pulmonary artery wedge pressure and pulmonary artery diastolic aresurrogate measurements for the pressure within the left atrium and thefilling pressure of the left ventricle, which is a typical area ofconcern in heart failure. It has been shown that the pulmonary arteryand left ventricular filling pressures correlate on most occasionsexcept for certain comorbidities such as primary pulmonary arterialhypertension. Such pressures change because of circulating volumeincrease (e.g. fluid retention) or declining pumping efficiency of theleft ventricle (e.g., thickening, dilation, or vasoconstriction of theperipheral resistance vessels).

Various attempts have been made to remotely monitor cardiac pressures inorder to identify more effective pharmacological treatment programs.These systems seek to monitor increases in intracardiac pressures toprovide an early predictor of an impending acute decompensation for apatient with prior history of heart failure (e.g., as a much morereliable indicator than other measurements such as weight gain, thoracicimpedance, etc.) For example, the CardioMEMS™ heart failure monitoringsystem by Abbott resides in the pulmonary artery and seeks toeffectively monitor pulmonary artery pressures as a surrogate for leftatrial pressure.

Other examples of remote monitoring systems include: Chronicle® byMedtronic and HeartPOD™ by Abbott/St. Jude. A short overview of each ofthese systems is provided below.

With Chronicle®, the measurement device resides in the right ventricleand reports an estimated pulmonary artery diastolic pressure (ePAD) to areceiving device. It has been stated that the measurements showed acorrelation between right ventricular diastolic pressure, rightventricular systolic pressure, and ePAD, with the increase in all thesepressure readings acting as indicators of an impending hospitalization.

HeartPOD™ uses a lead-and-can design with delivery of a measurementdevice by septal puncture method, with the measurement device remainingin the atrial septum and measuring left atrial pressure.

Another example includes the Vectorious™ left atrial pressure (LAP)monitoring system by Vectorious Medical Technologies which uses apressure sensor to measure the blood pressure within the left atrium.

Over the past several decades, the development of remote systems hasfocused on finding a reliable predictor of upcoming hospitalizationevents. Measuring left sided filling pressure and surrogates have shownto be the most reliable, predictive, and effective form of remotemonitoring. However, these systems show less information than acuteright heart catheterization, as such systems provide limited data foraccurately detecting root causes of the rise in pressure. One effect oflimited data, whether in the remote or acute setting, is that medicalservice providers are required to utilize trial and error medicationtechniques for patient treatment. This remote trial and error practicecan result in potential unnecessary harm to the patient, includingkidney damage, further heart failure disease progression, or undetectedcomorbidities. For this reason, physicians are careful with theirtitration increases (slow increases/decreases), use creatinine labtesting as a lagging metric to detect kidney damage due toover-diuresis, and are worried about arising comorbidities (such asundetected right heart failure), and bring the patient into the officefor further analysis, which may include the need for a right heartcatheterization in order to determine a safe and effective treatmentchange.

For example, a medical service provider may first try diuretics toreduce the monitored blood pressure, if they assume that the pressureincrease is due to a fluid retention issue. If this does not work, theymay increase the dosage of diuretics again. If this still does not work,the medical service provider may decide that the problem is not in thefluid retention, but vascular resistance, after which an attempt may bemade to use medications such as vasodilators. Lab creatinine testing mayfurther reveal that over-diuresis (hypovolemia) led to increased damageof the kidneys. In other words, treatment methods often rely heavily onan individual medical service provider's personal experiences andintuition, which not only vary from provider-to-provider andpatient-to-patient but may also extend the time needed to reliablyarrive at a correct diagnosis.

In general terms, there is an ongoing need for improved physiologicmeasurements to assist in proper treatment regimens for patients at riskof heart failure hospitalizations.

SUMMARY

Disclosed herein are medical devices, such as implantable measurementdevices, for performing measurements in a heart.

In an Example 1, a medical system for determining a treatment regimenfor a patient with a condition, the system comprising: at least onesensor configured to sense right atrial pressure and left atrialpressure; and a receiver configured to receive measurement datacorresponding to the sensed right atrial pressure and the sensed leftatrial pressure, and output to a display device the received measurementdata, wherein the condition is at least one selected from the group of:left heart failure, right heart failure, and primary pulmonary disorder.

In an Example 2, the medical system of Example 1, further comprising: amemory unit configured to store the received measurement data and thecondition of the patient; and a processor configured to determine, basedon the received measurement data and the condition of the patient, thetreatment regimen for the patient.

In an Example 3, the medical system of Example 2, wherein to determinethe treatment regimen of the patient, the processor is configured to:compare the sensed right atrial pressure to a baseline right atrialpressure; and compare the sensed left atrial pressure to a baseline leftatrial pressure.

In an Example 4, the medical system of either Examples 2 or 3, whereinto determine the treatment regimen of the patient, the processor isconfigured to: compare the sensed right atrial pressure and the sensedleft atrial pressure.

In an Example 5, the medical system of any one of Examples 2-4, whereinto determine the treatment regimen for the patient, the processor isconfigured to provide a notification to increase the dosage of thetreatment regimen.

In an Example 6, the medical system of any one of Examples 2-4, whereinto determine the treatment regimen for the patient, the processor isconfigured to provide a notification to decrease the dosage of thetreatment regimen.

In an Example 7, the medical system of any one of Examples 2-6, whereinthe processor is incorporated into an implantable medical device.

In an Example 8, the medical system of any one of Examples 2-6, whereinthe processor is incorporated into a device located external to thepatient.

In an Example 9, the medical system of any one of Examples 2-8, whereinto determine the treatment regimen of the patient, the processor isconfigured to provide a notification to increase at least one treatmentselected from the following group of treatments: vasodilators,diuretics, pulmonary vasodilators, neurohormonal antagonists, betablockers, and inotropes.

In an Example 10, the medical system of any one of Examples 2-8, whereinto determine the treatment regimen of the patient, the processor isconfigured to provide a notification to decrease at least one treatmentselected from the following group of treatments: vasodilators, diureticspulmonary vasodilators, neurohormonal antagonists, beta blockers, andinotropes.

In an Example 11, a computer-implemented method for determining atreatment regimen for a patient with a condition, the method comprising:receiving at least one measurement corresponding to a sensed rightatrial pressure for the patient; receiving at least one measurementcorresponding to a sensed left atrial pressure for the patient; andoutputting to a display device: the at least one measurementcorresponding to the sensed right atrial pressure, the at least onemeasurement corresponding to the sensed left atrial pressure, whereinthe condition is at least one selected from the group of: left heartfailure, right heart failure, and primary pulmonary disorder.

In an Example 12, the method of Example 11, further comprisingdetermining the treatment regimen for the patient based on: the at leastone measurement corresponding to the sensed right atrial pressure, theat least one measurement corresponding to the sensed left atrialpressure, and the condition of the patient.

In an Example 13, the method of Example 12, wherein determining thetreatment regimen of the patient comprises: comparing the sensed rightatrial pressure to a baseline right atrial pressure; and comparing thesensed left atrial pressure to a baseline left atrial pressure.

In an Example 14, the method of either Example 11 or 12, whereindetermining the treatment regimen of the patient comprises comparing thesensed right atrial pressure and the sensed left atrial pressure.

In an Example 15, the method of any one of Examples 12-14, whereindetermining the treatment regimen for the patient comprises providing anotification to increase the dosage of the treatment regimen.

In an Example 16, the method of any one of Examples 12-14, whereindetermining the treatment regimen for the patient comprises providing anotification to decrease the dosage of the treatment regimen.

In an Example 17, the method of any one of Examples 12-16, whereindetermining the treatment regimen of the patient comprises providing anotification to increase at least one treatment selected from thefollowing group of treatments: vasodilators, diuretics, pulmonaryvasodilators, neurohormonal antagonists, beta blockers, and inotropes.

In an Example 18, the method of any one of Examples 12-16, whereindetermining the treatment regimen of the patient comprises providing anotification to decrease at least one treatment selected from thefollowing group of treatments: vasodilators, diuretics, and pulmonaryvasodilators, neurohormonal antagonists, beta blockers, and inotropes.

In an Example 19, a monitoring system, comprising: a receiver configuredto receive measurements associated with the left heart pressure and theright heart pressure; a memory unit configured to store the receivedmeasurements; a display device; and a processing device configured to:compare the measurements associated with the left heart pressure and themeasurements associated with the right heart pressure; and output, tothe display device, the comparison.

In an Example 20, the monitoring system of Example 19, wherein theprocessing device is further configured to determine, based on thecomparison, a treatment regimen for the patient.

In an Example 21, the monitoring system of either Example 19 or 20,wherein the measurements associated with the left heart pressure areleft atrial pressure measurements.

In an Example 22, the monitoring system of any one of Examples 19-21,wherein the measurements associated with the left heart pressure aresurrogates for the left heart pressure, wherein the surrogates are atleast one surrogate selected from the following group of surrogates:pulmonary artery pressure (PAP), pulmonary arterial wedge pressure(PAWP), pulmonary artery systolic pressure (PASP), pulmonary arterydiastolic pressure (PADP), right ventricular systolic pressure (RVSP),estimated pulmonary artery diastolic pressure (ePAD), and leftventricular end-diastolic pressure (LVEDP).

In an Example 23, the monitoring system of any one of Examples 19-22,wherein the measurements associated with the right heart pressure areright atrial pressure measurements.

In an Example 24, the monitoring system of any one of Examples 19-23,wherein the measurements associated with the right heart pressure aresurrogates for the right heart pressure, wherein the surrogates are atleast one surrogate selected from the following group of surrogates:right ventricular end-diastolic pressure (RVEDP), central venouspressure (CVP), and jugular venous pulse (JVP).

In an Example 25, the monitoring system of any one of Examples 20-24,wherein the treatment comprises at least treatment selected from thefollowing group of treatments: diagnosis, medication titrations,advanced therapy, IV medications, lifestyle changes, intra-atrialshunts, valve repair/replace, ICDs, CRTs, and ablation.

In an Example 26, the monitoring system of Example 25, wherein themedication titrations comprise at least one titration selected from thefollowing group of titrations: vasodilators, diuretics, pulmonaryvasodilators, neurohormonal antagonists, beta blockers, and inotropes.

In an Example 27, the monitoring system of any one of Examples 25-26,wherein the advanced therapy comprises one or more selected from thegroup of: implanting a ventricular assist device (VAD), implanting amechanical circulator support (MCS), a transplant, or both.

In an Example 28, the monitoring system of any one of Examples 25-26,wherein the lifestyle changes comprise at least one lifestyle changeselected from the following group of lifestyle changes: a change indiet, increased activity, or both.

In an Example 29, the monitoring system of any one of Examples 19-28,further comprising a sensor configured to sense the measurementsassociated with the left heart pressure and the right heart pressure.

In an Example 30, the monitoring system of any one of Examples 19-29,wherein the processing device is further configured to output thedetermined treatment to a display device.

In an Example 31, the monitoring system of any one of Examples 19-30,wherein the processing device is further configured to diagnose, basedon the comparison, the patient.

In an Example 32, the monitoring system of any one of Examples 19-31,wherein the monitoring system is a closed loop system where trend dataof the measurements inform changes to an automated dispensing of amedicine.

In an Example 33, the monitoring system of Example 32, wherein themedicine is a diuretic, vasodilator, or both.

In an Example 34, the monitoring system of any one of Examples 19-33,wherein the monitoring system is a closed loop system where trend dataof the measurements inform changes to a ventricular assist device.

In an Example 35, the monitoring system of any one of Examples 19-34,wherein the monitoring system is used to determine RPM changes in aventricular assist device.

In an Example 36, the monitoring system of any one of Examples 20-35,wherein the processing device uses machine learning to modify thetreatment regimen.

In an Example 37, the monitoring system of any one of Examples 20-36,wherein the processing device is further configured to output to thedisplay device one or more of the following: left atrial pressure, leftatrial pressure averages, right atrial pressure, right atrial pressureaverages, trend arrows of the measurements, line graphs over time of themeasurements, waveforms of the measurements, and one or more medicationsof a patient associated with the measurements.

In an Example 38, a medical system for determining a treatment regimen,the system comprising: at least one sensor configured to sense rightatrial pressure and left atrial pressure; and a receiver configured toreceive a condition of the patient and measurement data corresponding tothe sensed right atrial pressure and the sensed left atrial pressure,wherein the condition is at least one selected from the group of: leftheart failure, right heart failure, and primary pulmonary disorder; amemory unit configured to store the received measurement data and thecondition of the patient; and a processor configured to determine, basedon the received measurement data and the condition of the patient, thetreatment regimen for the patient.

The foregoing Examples are just that and should not be read to limit orotherwise narrow the scope of any of the inventive concepts otherwiseprovided by the instant disclosure. While multiple examples aredisclosed, still other embodiments will become apparent to those skilledin the art from the following detailed description, which shows anddescribes illustrative examples. Accordingly, the drawings and detaileddescription are to be regarded as illustrative in nature rather thanrestrictive in nature.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the disclosure and are incorporated in and constitute apart of this specification, illustrate embodiments, and together withthe description serve to explain the principles of the disclosure.

FIG. 1A is a graph showing the utility in data from a surrogatemeasurement of left atrial pressure in reducing hospitalizations due toheart failure;

FIG. 1B is a schematic diagram of a heart and a lung of a patient usingthe prior-art measurement device (Swan Ganz right heart catheter) asdiscussed herein;

FIG. 2 is a cross-sectional diagram of a heart which uses a measurementdevice according to some embodiments;

FIG. 3 is a cross-sectional diagram of a heart which uses a measurementdevice according to some embodiments;

FIG. 4 is a cross-sectional diagram of the commissures of a tricuspidvalve;

FIG. 5 is a cross-sectional diagram of the commissures of a mitralvalve;

FIG. 6 is a schematic diagram of a heart and a lung of a patient using ameasurement device according to some embodiments;

FIG. 7 is a schematic diagram of a heart and a lung of a patient usinganother measurement device according to some embodiments;

FIG. 8 is a close-up view of a measurement device according to someembodiments;

FIG. 9 is a cross-sectional diagram of the content of right atriumelectronics in the measurement device of FIG. 8;

FIG. 10 is a cross-sectional diagram of the content of left atriumelectronics in the measurement device of FIG. 8;

FIG. 11 is a close-up view of a measurement device according to someembodiments;

FIG. 12 is a cross-sectional diagram of two examples of the contents ofright atrium electronics in the measurement device of FIG. 11;

FIG. 13 is a cross-sectional diagram of the contents of left atriumelectronics in the measurement device of FIG. 11;

FIG. 14 is a cross-sectional diagram of a heart which uses a measurementdevice according to some embodiments, where a portion of the measurementdevice is punctured by a trans-septal needle;

FIG. 15 is a close-up view of the measurement device of FIG. 14 beingpunctured;

FIG. 16 is a close-up view of another measurement device according tosome embodiments, where a portion of the measurement device is puncturedby a trans-septal needle;

FIG. 17 is a close-up view of a mesh configuration used in a measurementdevice according to some embodiments;

FIG. 18 is a schematic diagram of a wearable harness for an externalreader device for a measurement device according to some embodiments;

FIG. 19 is a schematic diagram of a syringe or catheter with a needlecontaining a sensor tethered to a wire according to some embodiments;

FIG. 20 is a schematic diagram of a sensor connected to a subcutaneousimplant according to some embodiments;

FIG. 21 is a cross-sectional view of a heart with the sensor implantedand immobilized using a pledget according to some embodiments;

FIG. 22 illustrates one example of a location of the subcutaneousimplant in the patient's body according to some embodiments;

FIG. 23 illustrates a block diagram of a method to determine actionsthat need to be taken based on pressure measurements according to someembodiments;

FIG. 24 illustrates a medication administration reference table usingtwo sets of measurement data as implemented by the method in FIG. 23;

FIG. 25 is a cross-sectional diagram of a measurement device accordingto some embodiments;

FIG. 26 is a cross-sectional diagram of a measurement device accordingto some embodiments;

FIG. 27 is a cross-sectional diagram of a measurement device accordingto some embodiments;

FIG. 28 is a cross-sectional diagram of a measurement device accordingto some embodiments;

FIG. 29 is a cross-sectional diagram of a measurement device accordingto some embodiments;

FIG. 30 is a cross-sectional diagram of a measurement device accordingto some embodiments;

FIG. 31 is a side view of a measurement device according to someembodiments;

FIG. 32 is a cross-sectional diagram of the measurement device of FIG.31;

FIG. 33 is a side view of the sensing element of FIG. 31 according tosome embodiments;

FIG. 34 is a schematic diagram of an electronics housing componentaccording to some embodiments.

FIG. 35 illustrates a flow diagram of a method for determining atreatment regimen for a patient according to some embodiments;

FIG. 36 illustrates an exemplary diagnostic table and an exemplarytreatment regimen table referenced by the method in FIG. 35 for apatient diagnosed with left heart failure;

FIG. 37 illustrates an exemplary diagnostic table and an exemplarytreatment regimen table referenced by the method in FIG. 35 for apatient diagnosed with right heart failure;

FIG. 38 illustrates an exemplary diagnostic table and an exemplarytreatment regimen table referenced by the method in FIG. 35 for apatient diagnosed with primary pulmonary disorder;

FIG. 39 illustrates an exemplary diagnostic table and an exemplarytreatment regimen table referenced by the method in FIG. 35 for apatient diagnosed with left heart failure and right heart failure;

FIG. 40 illustrates an exemplary diagnostic table and an exemplarytreatment regimen table referenced by the method in FIG. 35 for apatient diagnosed with left heart failure and primary pulmonarydisorder;

FIG. 41 illustrates an exemplary diagnostic table and an exemplarytreatment regimen table referenced by the method in FIG. 35 for apatient diagnosed with right heart failure and primary pulmonarydisorder; and

FIG. 42 illustrates an exemplary diagnostic table and an exemplarytreatment regimen table referenced by the method in FIG. 35 for apatient diagnosed with left heart failure, right heart failure, andprimary pulmonary disorder.

DETAILED DESCRIPTION

This disclosure is not meant to be read in a restrictive manner. Forexample, the terminology used in the application should be read broadlyin the context of the meaning those in the field would attribute suchterminology.

As the terms are used herein with respect to ranges of measurements“about” and “approximately” may be used, interchangeably, to refer to ameasurement that includes the stated measurement and that also includesany measurements that are reasonably close to the stated measurement,but that may differ by a reasonably small amount such as will beunderstood, and readily ascertained, by individuals having ordinaryskill in the relevant arts to be attributable to measurement error,differences in measurement and/or manufacturing equipment calibration,human error in reading and/or setting measurements, adjustments made tooptimize performance and/or structural parameters in view of differencesin measurements associated with other components, particularimplementation scenarios, imprecise adjustment and/or manipulation ofobjects by a person or machine, and/or the like.

Certain terminology is used herein for convenience only. For example,words such as “top”, “bottom”, “upper,” “lower,” “left,” “right,”“horizontal,” “vertical,” “upward,” and “downward” merely describe theconfiguration shown in the figures or the orientation of a part in theinstalled position. Indeed, the referenced components may be oriented inany direction. Similarly, throughout this disclosure, where a process ormethod is shown or described, the method may be performed in any orderor simultaneously, unless it is clear from the context that the methoddepends on certain actions being performed first.

Various embodiments are directed toward implantable medical devices suchas device for performing physiologic measurements in the left and rightsides of the heart. In certain instances, the various aspects of thepresent disclosure relate to methods and devices for performing pressuremeasurements. Additionally, the present disclosure also includes amedical treatment system for determining administration of medicationsto a patient based on the measurements performed.

Various examples relate to systems and methods for directly taking leftatrial and/or ventricular measurements (e.g., blood pressure). The leftside of the heart takes oxygenated blood from the lungs and distributesit to the rest of the body, while the right side of the heart carriesdeoxygenated blood from the body to the lungs. Various examples relateto sensor designs that avoid clots (emboli) and other unwanted sideeffects of placing a sensor in the heart. When a foreign object such asa sensor is implanted within the heart, a blood clot may form on thesurface of the implanted foreign object, which may break off and form anembolus. The damage done by an embolus varies depending on its location.If the implanted, foreign object is in the right side of the heart, theembolus would likely travel to the lungs, but if the implanted foreignobject is in the left side, an associated embolus could travel to anypart of the body, including an artery leading to the brain causingthrombotic stroke. In addition to effective, remote setting left sidemeasurements, various examples also relate to measuring in vivoconditions in two different portions of the heart (e.g., instead of onlymeasuring a single region).

FIG. 2 shows an embodiment of a measurement device 41 according to thepresent disclosure. The measurement device has a right-side sensingelement 10 and a left side sensing element 11, both of which sense andmeasure the pressure level within the respective side in which they areintegrated. For example, in this example, the right-side sensing element10 measures the pressure level in the right atrium 1, while the leftside sensing element 11 measures the pressure level in the left atrium 3of the patient's heart. The pressure sensing elements 10,11, mayincorporate MEMS technology such as but not limited to capacitive orpiezoresistive MEMs sensors or other pressure measurement means, assuitable, to measure intracardiac pressure levels.

As shown, the measurement device 41 has a right anchoring disc 8 and aleft anchoring disc 9 which work together to help hold the measurementdevice 41 in place. As shown in the figure, the two discs 8,9 aredesigned to sandwich the atrial septum 5 between the two atria 1,3(e.g., either actively engaging or contacting each side in an opposingmanner). The placement of the measurement device 41 can be achieved witha catheter procedure and septal puncture. The sensing elements 10, 11may be utilized along with a variety of devices that anchor to andextend across the atrial septum. Suitable examples may be found in avariety of Applicant's patent disclosures, including U.S. Pat. No.9,949,728, “Septal closure device with centering mechanism”;US20170042705 “Implantable Product with Improved Aqueous InterfaceCharacteristics and Method for Making and Using the Same”; U.S. Pat. No.9,861,346 “Patent foramen ovale (PFO) closure device with linearlyelongating petals”; U.S. Pat. No. 9,636,094 “Sealing device and deliverysystem”; and US20170105711, “Sealing Device and Delivery System.”

In the example of FIG. 2, the measurement device 41 leaves no hole aftersurgery because of the anchoring discs 8,9 acting as occluders. Themeasurement device 41 can be configured to promote tissue ingrowth(e.g., into the anchoring discs 8,9) for any of a variety of reasons,including better tissue integration, reduced erosion, reducedthrombosis, or other beneficial features. Reduction of thrombosis can beparticularly important on the left side of the heart. In someconfigurations, the measurement device 41 is configured such that theleft side sensing element 11 is relatively low profile (e.g., relativelyflat in profile). A relatively low profile may assist with reducing thepotential for thrombosis. In some examples, some level of tissueovergrowth over the sensor may also be permitted while still permittingproper functioning of the left side sensing element 11. For example, thepressure on the left side (e.g., left atrium) may be read through arelatively thin layer of tissue, if necessary.

FIG. 3 shows another embodiment of a measurement device 42 according tothe present disclosure. In addition to the anchoring discs 8,9 andsensing elements 10,11 shown in FIG. 2, there are also sensing tethers12,14 extending into the respective ventricles. Specifically, a rightventricle sensing tether 12 extends from the right side of themeasurement device 42 (e.g., from the right-side sensing element 10),into the right ventricle. A remote right ventricle sensing element 13may be attached to the right ventricle wall (e.g., using soft tissueanchors and/or tissue ingrowth features). The remote right ventriclesensing element 13 is configured to measure the pressure inside theright ventricle. The remote sensing element includes a MEMs sensor, forexample a piezoresistive embodiment, but does not necessarily includethe associated electronics and instead has wire leads providing thedirect signal transmission back to the electronics housing.

Similarly, a left ventricle sensing tether 14 extends from the left sideof the measurement device 42 (e.g., from the left side sensing element11) into the left ventricle. A remote left ventricle sensing element 15may be attached to the left ventricle wall (e.g., using soft tissueanchors and/or tissue ingrowth features). The remote left ventriclesensing element 15 is configured to measure the pressure inside the leftventricle.

The remote sensing elements 13,15 are configured to measure pressures indifferent portions of the heart than the sensing elements 10,11. In atleast this manner, the measurement device 42 is configured to provideadditional measurement data (e.g., left ventricular and rightventricular pressure data) for analysis. The sensing tethers 12, 14 maybe arranged or otherwise positioned to extend through the commissures ofthe valves that reside between the right atrium and the right ventricle(tricuspid valve) and the left atrium and left ventricle (mitral valve).FIGS. 4 and 5 show optional positions for the sensing tethers 12, 14,which include positions adjacent the commissures 59 located between theleaflets of the tricuspid valve 7 (FIG. 4) or the mitral valve 6 (FIG.5) through which the sensing tethers 12,14 extend to reach theirrespective ventricles. In various examples, by positioning the tethers12, 14 adjacent the commissures 59 the impact of the tethers on valvefunction and/or likelihood of thrombosis may be reduced.

In one example, additional sensors may be incorporated into the sensingtethers 12,14. In another example, the additional sensors may beimplemented into other elements of the measurement device 42 at thepoints of tether attachment to measure a force, i.e. tensile stress, onthe tethers 12,14. The force on the tethers 12,14 may be used as anindication of local blood flow velocity within the heart, and thismeasurement data may be used by itself or in combination with othermeasurement parameters to assess cardiac function of the patient.Advantages of measuring such force on the tethers 12,14 including theability to obtain data which serves as indicators relating to thecardiac function such as mitral inflow velocity, tricuspid flow, andseverity of a potential regurgitation, for example, which may bedifficult to detect using other means of measurement. To effectivelymeasure this force, the tethers 12,14 and remote sensing elements 13,15in this example are at least partially free-floating (i.e. not attachedto the walls of an atrium or ventricle). In addition to, or as analternative to measuring pressure and/or force, the various sensingelements may be configured to measure temperature (e.g., by includingone or more thermistor elements). By including temperature sensingcapabilities, a cold bolus (e.g., fluid) may be introduced into thecardiac system and the rate of temperature equalization may be used todetermine cardiac output at various locations in the heart. In contrastto methods that utilize a cold fluid bolus, various examples include useof a cold air bolus in the lungs to measure the rate at whichtemperature equalizes from blood returning from the lungs.

FIG. 6 shows how a cardiac output is affected by and therefore can bemeasured via thermodilution with a cold air bolus and a left atriumsensor, or thermistor 21, according to some embodiments. Initially, coldair bolus 24 is injected into the lung 22 (e.g., by introducinginhalation of a bolus of cold air into the lungs through the patient'strachea 23). Then, heat exchange 25 takes place when warmer deoxygenatedblood 26 enters the lung through the pulmonary artery 16 and is thencooled by the cold air bolus 24 during oxygenation. Afterwards, cooleroxygenated blood 27 leaves the lung through the pulmonary vein 17 intothe left atrium 3 where the thermistor 21, immobilized using the leftanchoring disc 9, measures the temperature in the left atrium 3. If moreblood is flowing, the temperature within the left atrium 3 would returnto normal temperature sooner than when less blood is flowing. As such,the inhalation of cold air in this case can be used to determine theinitial drop in the blood temperature in the left atrium 3, which isused to correlate the time for the temperature to return to normal. Therate at which the temperature returns to normal correlates with thecardiac output.

As a further additional or alternative feature, one or more O2 sensorsmay be included at one or more of the first pair of sensing elements10,11 and the remote second pair of sensing elements 13,15. FIG. 7 showsa diagram of blood flow from the right to left side of the heart througha lung and can be used to describe how cardiac output can be measuredvia O2 blood saturation sensors 28,29 (e.g., using Fick's Law).According to various examples, a right O2 saturation sensor 28 is placedin the right atrium 1 (e.g., associated with the sensing element 10immobilized using the right anchoring disc 8), and a left O2 saturationsensor 29 is placed in the left atrium 3 (e.g., associated with thesensing element 11 immobilized using the left anchoring disc 9), tomeasure the SvO2 and SaO2 levels in their respective areas ofmeasurement.

Fick's Law dictates that the blood flow to the patient's heart can becalculated using a marker substance, which in this case is oxygen (O2).The necessary data for making such calculations include the amount ofoxygen taken up by the heart per unit time, the O2 blood saturation inthe pulmonary artery, and the O2 blood saturation in the pulmonary vein.In this case, the O2 blood saturation of the pulmonary artery 16 ismeasured at the right atrium 1, and the O2 blood saturation of thepulmonary vein 17 is measured at the left atrium 3. Other data for thecalculation can include maximal oxygen uptake (VO2 max), which is themaximum rate of oxygen consumption measured during incremental exercise,and hemoglobin test, which in combination with the arterial and venouspercentages will determine oxygen concentration.

As explained above, different sensors can be implemented in theembodiments as disclosed herein (e.g., pressure, flow, temperature,and/or O2), with each measurement contributing vital data regarding thehealth of the patient's heart. The sensors themselves can be of variousshapes and sizes, as deemed suitable by a person of ordinary skills inthe art, to be implemented inside a patient's heart.

FIGS. 8-10 show additional details of possible sensor elementconfigurations. As shown in FIG. 8, a measurement device 43 has a rightatrium sensing element 30 included in right atrium electronics 37 and aleft atrium sensing element 31 included in left atrium electronics 38.The electronics 37,38 are attached to their respective anchoring discs8,9 as shown in FIG. 8. FIG. 9 shows that the electronics 37,38 bothinclude a control module 33 (e.g., printed circuit board) in a proximalpart 34 of a case 36 with regard to the anchoring discs 8,9. The case 36may be made of titanium, stainless steel, or other suitable materials.The right atrium electronics 37 further include the right atrium sensingelement 30 and an antenna coil 35. The left atrium electronics 38further include the left atrium sensing element 31 and a power source 32(e.g., battery and/or wireless power source). In this configuration, anexternal reader device, such as the external charger and communicationsrelay 70 in FIG. 18, charges the power source 32 as well ascommunicating with the electronics 37,38 to obtain the measurement datastored in a memory implemented in the control modules 33.

The control modules 33 can be designed such that they are configured toperform a sequence of steps for taking measurements within differentportions of the heart (e.g., each of the chambers), whether themeasurements are in blood pressure, temperature, and/or oxygensaturation), as well as to store the data until the external readerdevice can access the data, usually wirelessly. Furthermore, the powersource 32 can be any suitable power source that can be used in thisimplementation. For example, the power source can be coupled to acharging coil which enables inductive charging of the power source suchthat the external reader device can remotely charge the power sourcefrom outside the patient's body, which reduces the need to exchange thepower source once it runs out of power. For example, the antenna coil 35can be used as a charging coil in addition to performingrelay/communication functions.

FIGS. 11-13 show various configurations that may be used in variousexamples. As shown, the left atrium electronics 38 of a measurementdevice 44 only include the left atrium sensing element 31 (e.g.,sensing, temperature and/or O2). Minimizing the number ofcomponents/elements on the left side of the device may help minimize theoverall size of the device and the associated amount of foreign materialin the left atrium. As described above, this may reduce the potentialfor thrombosis and foreign body response. As such, in various examples(e.g., as shown in inset view of the configuration 39B), the rightatrium electronics 37 include the power source 32 to power the sensingelements 31, any associated data storage elements, and more generallythe control module 33. In another example as shown in configuration 39Aof the inset view of FIG. 12, the right atrium electronics 37 do notinclude an onboard power source. In such embodiments, measurement datamay only be taken when an external reader device is engaged to power themeasurement device 44 (e.g., using inductive power to activate thesensing elements 30,31 and control module 33).

In various examples, one or more of the measurement devices 41,42,43,44(e.g., one or both of the anchoring discs 8,9) is configured to befenestrated, or crossed by a surgical implement (e.g., trans-septalneedle) following implantation. FIGS. 14 and 15 show a puncture needle51 attached to the end of a catheter sheath 50 penetrating the surfacesof the anchoring discs 8,9 to indicate that the measurement device 45 isre-crossable (e.g., may be penetrable by a needle and followed by asheath).

During certain procedures or operations, it may be imperative to enterthe left atrium 3 even though the measurement device 45 has beenimplemented in the atrial septum 5 between the atria 1,3. In such case,the measurement device 45 is configured to have re-crossable surfaces inthe anchoring discs 8,9 so that the puncture needle 51 can penetratethese surfaces to perform the procedures. FIG. 14 shows the needle 51and catheter sheath 50 entering the right atrium 1 from the inferiorvena cava 53, but in some instances may enter the right atrium 1 fromthe superior vena cava 52 as necessary. In this embodiment, the surfaceof the anchoring discs 8,9 includes a material than can be safelypenetrated, such as an expanded polytetrafluoroethylene (ePTFE) membrane54, although other suitable materials can be implemented to providere-crossing capability. The outer edge of the anchoring disc 9 isdefined by a nitinol frame 55 which also extends radially from the leftside sensing element 11 to the outer edge, although other suitablematerials may be used for the frame as well. The needle 51 forms apuncture hole 56 in the membrane 54 to allow for the catheter sheath 50to pass through.

FIG. 16 shows another embodiment as disclosed herein where the left sidesensing element 60 of a measurement device 46 is located on a portion ofthe left anchoring disc 9. For example, the left side sensing element 60may be located on membrane material (e.g., ePTFE membrane 54) of theleft anchoring disc 9, as opposed to the frame of the left anchoringdisc 9 (e.g., center eyelet or outer frame). In this embodiment, theleft side sensing element 60 is coupled to the membrane 54 to helpprevent the sensing element 60 from protruding outward from the septalwall or reduce the amount the left sensing element 60 protrudes from theseptal wall from the measurement device 46. In this embodiment, anantenna coil 61 is implemented in the anchoring disc 9. As shown, thesensing element 60 is attached to the antenna coil 61, and the antennacoil 61 is wrapped around the ePTFE membrane 54 to form the outer edgeof the left anchoring disc 9, thereby defining the periphery of the leftanchoring disc 9. Additional embodiments may further reduce the amountthe left sensing element 60 protrudes from the septal wall. For example,in one embodiment, the left anchoring disc 9 may be replaced with asmall tissue anchoring structure which help align the outer surface ofthe left sensing element 60 to be substantially flush with the surfaceof the surrounding septal wall, such that the sensing element 60 wouldnot visibly protrude from the septal wall. For example, small hooks orother suitable structures may be implemented to hold the left sensingelement 60 in place. In another embodiment, a cover or other similarcomponent may be employed over the left sensing element 60 to preventthe sensing element from substantially protruding into the left atrium.The cover may be made of a material that is chemically inert such as lowtemperature isotropic (LTI) carbon and diamond like carbon (DLC), orpolymers such as polytetrafluoroethylene (PTFE), expanded PTFE, orpolyethylene terephthalate (PET). In some examples, the cover may be athin film placed over the left sensing element 60 to promote tissueingrowth over the sensing element.

FIG. 17 shows another potential configuration for the medical device 46where the left anchoring disc 62 uses a frame (e.g., nitinol) configuredinto a mesh design that defines the left and/or right disc(s). Theconfiguration of FIG. 17 may or may not employ a cover or membrane 54(e.g., ePTFE). The re-crossable surface is designed such that catheterswith a French gauge suitable to fit between the frame elements (e.g., upto 24 Fr) may fit through the anchoring disc(s) without interfering withthe electronics. Also, it should be appreciated that although theanchoring discs illustrated in the figures are relatively flat andcircular in structure, any of the anchoring disc configurationsdescribed herein can use other shapes (e.g., rectangular, triangular,etc.) as well. Moreover, the anchoring discs may be configured with acurved side profile (e.g., concave and/or convex) to accommodate for thedifferent contours defining the surface within the heart to which theanchoring discs are to be engaged.

In one embodiment, the measurement device 45,46 can also act as atherapeutic device, such as an intra-atrial shunt, a controllableintra-atrial shunt, an occluder for atrial septal defects (ADS), and soon. The measurement device 45,46 can act as such a controllable shuntbecause it is located at an interatrial septum between the left andright atria, and the membrane 54 can be opened via interventional ornoninvasive procedures. As such, the membrane 54 may be expanded,contracted, opened, closed, fenestrated, sealed, punctured, resealed,traversed, or crossed using appropriate tools during differentprocedures to actuate the controllable shunt. The use of a needle tomake a puncture hole 56 in the membrane 54 as discussed above is oneexample of the interventional procedure. Other interventional proceduresinclude mechanical, thermal, laser, ultrasound, and inductive methods.On the other hand, the opening of the hole can be triggered viawireless, extracorporeal energization, including inductive energytransfer and ultrasound energy transfer. In one embodiment, the membrane54 can be melted to form an opening after exposing the membrane 54 tothermal or ultrasound energy, i.e. via thermal activation. An advantagein having an opening in the membrane 54 includes, when the measurementdevice 45,46 is located between the left and right atria, reducing theleft atrial pressure when it rises to a life-threatening level. Oneadvantage in this configuration is that even after the opening isformed, the measurement device 45,46 can continue taking measurementswithin the two atria. The size of the shunt can be adjusted based on therequired degree of pressure relief. For example, if the pressure issignificantly higher than the normal level such that the pressure mustbe lowered immediately, the shunt can be opened wider. When the shunt isopened via mechanical piercing or thermal ablation, it can preventembolization as well. Furthermore, a pressure-sensitive valve may beimplemented in the measurement device 45,46 such that the membrane 54opens to form the shunt above a threshold pressure level. In anotherexample, the valve may also track and transmit its status (i.e. whetherthe shunt is open or closed in the valve, as well as the degree ofopening in the shunt) which may serve as an indication of a pressuredifferential within the heart. Therefore, a remote monitoring system(for example a remote device 72 in FIG. 18) which receives data from thevalve can use the status data of the valve to determine a difference inpressure between the left and right atria.

FIG. 18 shows an example of external charging and communications relayaccording to some examples. As shown, the external charger andcommunications relay 70 is a device which can charge or power a powersource of the measurement device (for example, the battery 32 in themeasurement devices 43,44) via electromagnetic induction, as well as tocommunicate with the measurement device 43 or 44 to obtain themeasurement data. In one example, the external charger communicationsrelay 70 is a device which inductively couples with the measurementdevices 43,44 to directly power the measurement devices 43,44 such thatan on-board power source, for example a battery implemented within themeasurement devices 43,44, is not required. In one example, the externalcharger communications relay 70 wirelessly powers the measurementdevices 43,44 via radiofrequency (RF) electromagnetic radiation. Theexternal charger and communications relay 70 may be worn (e.g., using aharness 71) such that the location of the charger and relay 70 is placedat an operable location for the charger and relay 70 to charge andobtain data from the measurement device. A monitoring system 72, whichcan be a smart device such as a smartphone, can be used by the patientor other party (e.g., medical service provider or remote monitoringfacility) to receive information regarding the measurement data via anapplication software in the monitoring system. For example, the remotedevice 72 can visually show the blood pressure, temperature, and/oroxygen saturation in a simple, user-friendly interface. If the patientis visually impaired or prefers audio notifications, the remote device72 can provide audio output to alert the patient if the sensormeasurements indicate that the patient's heart may be at risk of acutedecompensation episodes, so that the patient can go to a hospital for afurther examination. The remote device 72 can also upload themeasurement data onto a server (not shown) to be collected by medicalservice providers or a database to remotely monitor the conditions ofthe patient's heart.

Based at least upon the foregoing, it should be appreciated that avariety of sensor locations are contemplated and may be implemented inany combination.

For example, to measure the left ventricular pressure, a tethered sensorcan be sent off the left anchoring disc, between the mitral valveleaflets, and into the left ventricle, where tissue ingrowth canimplement the sensor into the wall of the left ventricle. The sensordirectly measures the left ventricular systolic and diastolic pressure,which also gives a direct indication of systolic systemic bloodpressure.

To measure the aortic pressure, the tethered sensor can be sent off theleft anchoring disc, between the mitral valve leaflets, through theaortic valve, and into the aorta, where the sensor is secured to thewall of the aorta. This placement allows for direct measurement of theaortic pressure which gives a direct indication of systolic anddiastolic blood pressures.

To measure the right ventricular pressure, the tethered sensor can besent off the right anchoring disc, between the tricuspid valve leaflets,and into the right ventricle, where tissue ingrowth can implement thesensor into the wall of the right ventricle. The sensor directlymeasures the right ventricular pressure which gives a direct indicationof systolic and diastolic right ventricular pressures.

To measure the pulmonary artery pressure, the tethered sensor can besent off the right anchoring disc, between the tricuspid valve leaflets,through the pulmonary valve, and into the pulmonary artery, where it issecured. This placement allows for direct measurement of the pulmonarypressure which gives a direct indication of pulmonary status viapulmonary systolic and diastolic pressures.

Furthermore, the implanted device that measures the left and rightatrial pressures can be used in combination with other medical devices.Examples of such medical devices include, but are not limited to, bloodpressure cuffs, pulse-oximeters, scales, creatinine testing devices,smart devices, and wearable medical tracking devices, to name a few. Themeasurement device 41 can also be combined with other implantabledevices, such as a ventricular assist device (VAD), drug delivery shuntor system, or other device. The measurement device 41 may providefeedback to the other implantable device(s), as part of a closed loop oropen loop feedback system. The VAD may be a right VAD, a left VAD, or abi VAD.

FIGS. 19 to 22 show additional sensor element examples as well as theassociated delivery systems and methods. As shown, the left side sensingelement 11 may be coupled with a tether 80, with the sensor element 11and tether 80 configured to delivered through a needle delivery system81 shown schematically in FIG. 19. Generally, the delivery system 81 mayinclude a catheter and associated delivery needle 82 at a distal end ofthe catheter that is used to access a target area in the body (e.g., viaultrasound, radiographic, optical or other guidance). For example, theneedle may be used to puncture a wall of the heart (e.g., left atrialwall) and the left side sensing element 11 may be advanced through theneedle 82 into the target space (e.g., the left atrium). The needle 82may then be retracted and the sensing element 11 may be pulled ortensioned against an inner wall of the heart (e.g., the inner walldefining the left atrium). A pledget or other anchor 84 may be advanced(e.g., over the tether 80) to a position on an opposite side of theheart wall from the sensing element 11 (e.g., a location on an outerwall of the heart proximate to the location of the sensing element 11)to help secure the sensing element 11 in place (e.g., as shown in FIG.21). The tether 80 may be connected to a subcutaneous implant 83 thathandles power, signal processing, and data transmission functions asshown in FIG. 20.

The subcutaneous implant 83 can include a battery, an antenna, and acontrol module (e.g., a microchip) to help control data collection andcommunication functions. In one example, the measurement device 47 mayinclude a plug 85 that is placed between the sensing element 11 and thepledget 84 to help fill the fenestration left by the needle 82.

FIG. 22 shows a subcutaneous implant 83 on the other end of the tether80 opposite from the sensing element 11. Multiple sensor elementssimilar to the left side sensing element 11 can be placed in anydifferent parts of the heart as deemed suitable by the medical serviceproviders. For example, after the left side sensing element 11 is placedin the left atrium, another sensing element such as the right-sidesensing element 10 can be implemented into the right atrium using thesame technique that is used to place the sensing element 11 in the leftatrium. Another similar sensing element can be implanted in the leftventricle, right ventricle, or any other location in the heart orvasculature as desired. As such, any number of sensor elements can beimplemented by penetrating a wall of the heart to take measurements(pressure, temperature and/or oxygen saturation) in any of the chambersof the heart or associated vasculature.

The tether(s) associated with the sensor elements can be coupled to thesame subcutaneous implant or different subcutaneous implants as desired.Whether a single subcutaneous implant with data receiving andcommunication capabilities or different subcutaneous implants, it shouldbe understood that any of the combination of measurements (pressure,temperature and/or oxygen saturation) at any combination of locations(e.g., left atrium, right atrium, left ventricle, and/or rightventricle) may be realized using the tethered sensor elements describedin association with FIGS. 19 to 22.

The pressure measurement data obtained using the sensing elements10,11,13,15 as described herein can be used to perform pulse-contourmethod, which is another method that is used to measure the cardiacoutput of the patient. This method uses the continuous pressuremeasurement data to plot a pressure-versus-time graph for the patient'sheart, after which the pressure integral, i.e. the area beneath theplotted line on the pressure-versus-time graph, is used to determine thestroke volume (SV) of the portion of the heart that is being measured.The value of SV multiplied by the heart rate is the cardiac output.

FIG. 23 is a flow chart showing a remote medical treatment monitoringmethod 99 that can be implemented using one or more electronic devices,such as the monitoring system 72, using measurement data received fromthe measurement device 41, for example, or any of the sensor elementsdescribed herein. In some examples, the method 99 is used for patientswith a history of left heart failure (LHF), to determine treatmentprotocols guided by measured right and left heart physiologic metrics(e.g., pressure, temperature, and/or oxygen saturation).

Regardless, in some embodiments, in an optional first step 90 theservice provider determines if the patient receiving treatment has ahistory of either left heart (LH) or right heart (RH)/biventricularfailure. The method 99 may be used for patients with a risk of LH orRH/biventricular failure as determined by the medical service providers,regardless of history. In optional step 91, the medical service providerset a baseline “normal” level for applicable physiologic metrices (e.g.,the left and right atrial pressures) in the acute setting by performingvarious tests on the patient to determine, based on the currentcondition of the patient, what normal levels (pressure, cardiac output,and/or oxygen saturation) would be. Baseline values can then be enteredinto the system which transfers the data to the monitoring system 72. Inthe example illustrated in this figure, the pressures being measured arethe left atrial pressure (LAP) and the right atrial pressure (RAP).Other embodiments may include other measurements of other parts of theheart, as deemed appropriate by the medical service provider.

In some examples, the monitoring system 72 receives RAP and LAPmeasurements from the sensors in step 92, such as the right-side sensingelement 10 and the left side sensing element 11. In one implementation,the measurements include whether the pressure values of the right atriumand the left atrium are trending below, at, or above the normal level.In another example, the method may also consider whether the pressurevalues are increasing, decreasing, or staying steady as an additionalinput into the overall assessment.

In optional step 93, the monitoring system 72 confirms whether thepatient has a history of LH or RH/biventricular failure. The monitoringsystem 72 optionally uses a medication administration reference table100 in FIG. 24 to determine and indicate if dosage of certainmedications needs to be increased or reduced, in step 94. Alternatively,a medical service provider (e.g., physician) optionally uses the datadirectly to assess what treatment regimen (e.g., pharmacological) isappropriate based upon the data using the methodology of table 100.

As shown, the table 100 has three columns and three rows, where thecolumns pertain to “RAP trending below normal” 101, “RAP trendingnormal” 102, and “RAP trending above normal” 103, and the columnspertain to “LAP trending below normal” 104, “LAP trending normal” 105,and “LAP trending above normal” 106. For example, if the RAP is trendingbelow normal but the LAP is trending above normal, the method wouldinclude the step of “Increase Vasodilators” according to the table 100.If automated, a consistent “message” or communication could be relayedto a user of the monitoring system. On the other hand, if the RAP isalso trending above normal, the method would include the step of“Increase Diuretics”. Again, if automated, a consistent “message” orcommunication could be relayed to a user of the monitoring system. Itshould be noted that when the LAP and RAP values are both in the normallevel (i.e. the box defined by the “LAP normal” row and “RAP normal”column), one method would include not altering any medications.

After the initial medication is administered, the method 99 includesverifying to see if the RAP is still trending above normal and if theRAP value is unaffected by diuretics, in step 95. This may occur in thesecond example shown above, where the LAP and RAP are both trendingabove normal, so the amount of diuretics administered to the patient isincreased, but a subsequent measurement of the RAP shows that thispressure is still above normal. In this instance, the monitoring system72 could display an indication in step 96 instructing the medicalservice provider to bring the patient in for a potential diagnosis of RHfailure (or the medical service provider could carry out the step 96based upon the data). Among other possible causes of high RAP is primarypulmonary arterial hypertension. When the medical service provider teststhe patient for possible diagnosis of these conditions, the medicalservice provider can set a new baseline value range for the “RAP normal”level and update the patient's status as having a history ofRH/biventricular failure so that moving forward, the method will proceedto step 97 instead of step 95 in the future. Otherwise, if the RAPdecreases to the normal level, the monitoring system 72 optionally goesback to step 92 to take subsequent RAP and LAP measurements.

Returning to step 93, if the monitoring system 72 (or the medicalservice provider) confirms that the patient has a history ofRH/biventricular failure, the method 99 proceeds to step 97 afterdetermining which medication to increase or decrease based on analysisoutlined in table 100. In step 97, the method 99 includes determining ifthe medication administered in step 94 is effective. For example, themethod 99 may include comparing the previous LAP and RAP values with thenew LAP and RAP values taken after the medication is administered. Ifthe comparison shows that there is an insufficient change in the statusin a way that indicates that the administered medication is ineffective(for example, if the LAP or RAP is still below normal and the medicationis not causing it to increase toward normal level, or if the LAP or RAPis still above normal and the medication is not causing it to decreasetoward normal level, etc.) the medical service provider may bring thepatient in for adjusted treatment and/or the monitoring system 72 mayprovide a message or other communication indicating that furtherdiagnosis/treatment is warranted in step 98. The possible lack ofefficacy of the medications may be a sign of increased exigency or thatimmediate medical attention is otherwise warranted. Otherwise, if theadministered medication is showing apparent efficacy in moving LAP andRAP toward nominal or desired levels, the method returns to step 92 andthe monitoring system 72 continues to receive and evaluate newmeasurements for assessing patient health.

Use of at least two sets of measurement data (in this example, LAP andRAP measurements) in assessing cardiac function is advantageous overprior-art methods with only one set of measurement data for a variety ofreasons, including that the second set helps facilitate more accurateroot cause diagnosis and treatment.

In another embodiment, the method 99 may be programmed so that insteadof using the actual measured LAP and RAP values, a ratio of LAP to RAP(or a ratio of RAP to LAP) may be used to determine which medications toadminister and how much. This methodology may be based on theunderstanding that the pressures within the left and right atria shouldcorrespond to a desired ratio (e.g., 2:1 LAP:RAP) in a healthy heart,therefore the ideal ratio of LAP to RAP can be determined (e.g., anideal ratio of 2:1 pressures are desired), and any ratio that issignificantly smaller or larger than the desired ratio (e.g., 2:1) wouldpose a threat to the patient's health.

In some examples, if the ratio of LAP to RAP is above a threshold value(i.e. the LAP is much higher than the RAP) and keeps increasing in apatient with a history of LH failure, the method may include adetermination that the amount of vasodilators being administered shouldbe increased. The threshold ratio value of LAP to RAP which triggerssuch a determination may be determined and updated periodically by themedical service provider (e.g., after examination performed on thepatient). In other words, various methods include one or more medicalservice providers determining the range of “normal” baseline ratios,which will then be used in the medication administration referencetable. Alternatively, a generalized set of guidelines may be provided tomedical service providers regarding an appropriate baseline.

The method 99 can be adjusted to be more specific in terms of how much apharmacological, or medication regimen needs to be increased or reduced,which can be varied based on how much the LAP and RAP are trending aboveor below the normal level. This may be done by implementing anothertable or set of guidelines within the table 100 that indicates theamount of medication to be administered (e.g., so that a treatmentdosage may be adjusted for a patient without requiring direct medicalservice provider intervention). The table 100 can include any of avariety of medical recommendations/indications, such as beta-blockersand inotropes, for example, as indicated by a particular set ofphysiologic measurements and associated guidance of the table 100.Furthermore, to inform the patient on which medication to choose and itsdosage, the type of medication (e.g. diuretic or vasodilator) that needsto be administered and the dosage thereof can be displayed on, forexample, the screen of a computer or a display of a smart device used bythe patient.

As referenced above, the measurement data and associated monitoring andtreatment methodology is not necessarily limited to LAP and RAPmeasurements. In some examples, additional or alternative locations(e.g., pulmonary arteries, ventricles, pulmonary veins, aorta, andothers) and/or additional or alternative metrics (e.g., temperatureand/or oxygen saturation) may be utilized in implementing a monitoringand treatment method such as the method 99.

As explained above, the method 99 may be performed manually or may bepartially or completely automated using any device capable of receivingand processing the measurement data from the measurement device 41. Forexample, the method 99 may be implemented entirely in the monitoringsystem 72 (e.g., such as a smart device), which performs all thecomparisons, calculations, and determinations after receiving the LAPand RAP measurement data from the measurement system 41. In someexamples, the method may be implemented partially in the monitoringsystem 72 and partially in the communications relay 70 which may includea processing unit to receive the LAP and RAP measurement data from thesensors, determine whether the LAP and RAP are above/at/below normallevel and decreasing/steady/increasing, then relay this information tothe remote device 72 to perform the rest of the method. In yet anotherexample, the subcutaneous implant 83 may be programmed to perform aportion or the entirety of the method.

In still further examples, the method 99 may be implemented in a devicewith a user interface allowing the patient to administer medicationsaccording to the results of the method. The method may also beimplemented in the medical service providers' electronic health record(EHR) or electronic medical record (EMR) systems which keep track of thenecessary records of each patient. As such, the EHR or EMR systems mayuse local or remote database to access, among other things, thepatient's history of LH or RH/biventricular failure and whether themedical service providers have deemed the patient to be at a risk ofsuch failure. The resulting data from the method may be displayed on adashboard of the user interface with multiple options for the user (e.g.patient and medical service providers), which may include: LAP and RAPaverages, trend arrows, line graphs over time, and waveforms, as well asa history of the medications taken by the patient, etc. The dashboardmay also be configured such that the user can first pull up the mostmeaningful information, such as the averages and trends, then dig infurther for a more detailed analysis, such as the waveforms. This may beimplemented by organizing the multiple options in a hierarchical mannerbased on the importance of each option. In one example, thishierarchical order of the options is customizable according to theuser's preference, such that the most preferred information can bepulled up first.

FIG. 25 shows an embodiment of a measurement device 110 according to thepresent disclosure. The measurement device 110 has an electronicshousing component 114 which stores an antenna, for example the antennacoil 35, and the battery or power source 32, as shown in FIG. 34, suchthat after the measurement device 110 including the housing component114 is inserted through an aperture formed on the atrial septum 5, thehousing component 114 protrudes from and extends beyond both walls ofthe septum 5 and the anchoring discs 8,9. The antenna 35 transmits themeasurement data taken by the sensing elements 10,11 to an externalmonitoring system (not shown) which receives, tracks, and performsanalysis of the data. The measurement device 110 has the right anchoringdisc 8 and the left anchoring disc 9 working together to help hold thehousing component 114 in place so that the housing component 114 issecured in position relative to the septum 5. As shown in the figure,the two discs 8,9 are designed to sandwich the atrial septum 5 by eitheractively engaging or contacting each side in an opposing manner. In oneexample, the housing component 114 is made of a suitable metal such astitanium, stainless steel, or other biocompatible metal. In anotherexample, the housing component 114 is made of plastic or other suitablepolymeric material. In still other examples, the housing component 114is formed of a biocompatible ceramic material, such as glass.

The sensing elements 10,11 are implemented or disposed in the housingcomponent 114 such that these sensing elements 10,11 are located on thetwo ends of the housing component 114 that extended into the atria. Insome examples, the sensing elements 10, 11 protrude into the atria toenable better sensing functionality. For example, in some examples, itmay be more beneficial to have the sensing elements 10, 11 located atthe two ends of the housing component 114 to space the sensing elements10, 11 from the septum 5 in order to prevent tissue ingrowth fromaffecting the measuring efficacy of the sensing elements 10, 11.

One advantage of having the sensing elements 10,11 protruding into theatrium and raised above the surface of the septum 5 is that the sensingelements 10,11 may perform more effective (e.g., accurate) physiologicmeasurements chronically than if the sensing elements 10,11 were locatedrelatively flush with the septum 5. In some examples, a layer ofanticoagulant agent 120, as shown in FIG. 25, is disposed over a portionor an entirety of a surface proximate one or both of the sensingelements 10, 11 to effectively reduce the risk for thrombus forming onthe device or due to turbulence of flow that could lead to stroke orembolic events. The layer of anticoagulant agent 120 may be positionedover one or more of the housing component 114, the sensing elements10,11, and/or the anchoring discs 8,9, for example.

Possible anticoagulant agents which may be used include but are notlimited to: heparin, warfarin, rivaroxaban, dabigatran, apixaban,edoxaban, enoxaparin, and fondaparinux. In one example, the layer 120may be a layer of anti-inflammatory agent such as dexamethasone toreduce inflammation of the tissues proximate to the sensing elements10,11 to improve accuracy of the measurements. In some examples, thelayer of anticoagulant agent 120 is formed by a CBAS® Heparin Surfacetreatment available from W. L. Gore & Associates, Inc.

FIG. 26 shows an embodiment of a measurement device 112 according to thepresent disclosure. In the measurement device 112, the housing component114 is positioned such that one end of the housing component 114 issubstantially flush with the corresponding anchoring component, in thisexample the anchoring disc 9, thereby reducing the amount of flowdisruption and subsequent potential for device related thrombus. As aresult, there is a need to control the tissue growth to enable reliable,chronic sensor performance. As such, a layer of biocompatible material116 is disposed on a portion or an entirety of a surface of one or moreof the housing component 114, the sensing elements 10,11, and/or theanchoring discs 8,9. The biocompatible material with a suitablestructure which controls tissue ingrowth, such as expandedpolytetrafluoroethylene (ePTFE), for example. Other examples of thebiocompatible material include but are not limited to suitable polymericor synthetic materials or naturally occurring materials such aspolyethylene terephthalate (PET), polyethylene (PE), polypropylene (PP),Silicone, polylactic acid (PLA), polyglycolide (PGA), PolyglycolicAcid:Trimethylene Carbonate (PGA:TMC), Stainless Steel, Nitinol,decellularized tissue matrix, fluorinated ethylene propylene (FEP),copolymers of tetrafluoroethylene (TFE) and perfluoro(propyl vinylether) (PFA), homopolymers of polychlorotrifluoroethylene (PCTFE), andits copolymers with TFE, ethylenechlorotrifluoroethylene (ECTFE),copolymers of ethylene-tetrafluoroethylene (ETFE), polyvinylidenefluoride (PVDF), and polyvinyfluoride (PVF). Other examples of thestructures include but are not limited to suitable wovens, non-wovens,braids, knits, films, or microporous films including electrospun webs,expanded polymers, foams, melt-blown webs, etc. The tissue whoseingrowth is promoted may be vascular endothelial cells.

FIG. 27 shows an embodiment of a measurement device 118 according tovarious examples. The measurement device 118 further includes theadditional layer of anticoagulant agent 120 on top of the layer ofbiocompatible material 116 from FIG. 26. In one example, the layer 120is of sufficient size to cover the surface of the sensing element 11such that the anticoagulant agent hinders tissue ingrowth over thesensing element 11, thereby minimizing errors in the physiologicmeasurements performed by the sensing element 11 or otherwise enhancingefficacy of the sensing element 11 over time (e.g., precision and/oraccuracy).

In another example, the layer 120 can cover a smaller or larger area ofthe layer 116 depending on the implementation. Other examples of filmlayer can allow selective tissue ingrowth such that the tissue ingrowthis permitted or encouraged around a perimeter portion of the anchoringdisc 9 (or portions thereof) while providing a “window” or portion withlesser or no tissue ingrowth corresponding to the area on and/orsurrounding the sensing element 11. For example, the layer ofbiocompatible material 116 can have the anticoagulant agent imbued orincorporated into a certain area so the tissue ingrowth is reduced orminimized in that certain area to optimize function of the sensingelement 11. In view of the above, different combinations of agents andpolymers may be used to adjust the amount of tissue ingrowth that isachieved such that there is sufficient tissue ingrowth and anchoring butnot so much that the tissue hinders effective measurement by the sensingelements 10,11.

FIG. 28 shows an embodiment of a measurement device 122 according to thepresent disclosure. The measurement device 122 the sensing elements10,11 are disposed in the anchoring discs 8,9, respectively. The surfaceof the disc 9 and the sensing element 11 is covered with the layer 116as previously explained, and the surface of the disc 8 and the sensingelement 10 is covered with another layer 124 of the same biocompatiblematerial as the layer 116 so that tissue ingrowth is promoted over bothdiscs. In one example, the biocompatible material used may differbetween the two layers 116, 124. In some examples, the housing component114 extends through the second layer 124 but is substantially flush withthe first layer 116.

The sensing elements 10,11 in some examples are located or otherwisepositioned relative to one another such that the sensing elements 10,11align with each other across, or on opposite sides of, the atrial septum5. That is, the distance between the sensing elements 10,11 is reducedto help minimize the overall surface area of the septum taken up by thesensing elements 10,11. One advantage of this configuration is that theremaining space occupied by the discs 8,9 that are not occupied by thesensing elements 10,11 is available in the event that an opening oraperture (fenestration) is to be formed on the atrial septum 5 tofacilitate access across the septum (e.g., as part of a device deliveryfrom the right to left side of the atrium), selective fluid flow, or forother purpose as desired.

As previously shown in FIGS. 14-16, the anchoring discs 8,9 may havere-crossable surfaces such that the opening or aperture can be formedwithout interfering with the electronics. In one example, themeasurement device 112 can act as an intra-atrial shunt if placedbetween the left and right atria of the heart. FIG. 29 shows anembodiment of a measurement device 126 where the sensing elements 10,11are located such that the positions of the sensing elements 10,11 areoffset with each other across the atrial septum 5, and therefore aregenerally not aligned across the septum. In one example, an anglemeasured between the positions of the sensing elements 10,11 withrespect to a longitudinal axis of the housing component 114 (or angularoffset) may be less than 15 degrees, between 15 and 30 degrees, between30 and 45 degrees, between 45 and 60 degrees, between 60 and 90 degrees,between 90 and 135 degrees, and between 135 and 180 degrees, forexample, although a variety of arrangements are contemplated. FIG. 29illustrates an example in which the angle is 180 degrees, and thisconfiguration achieves maximum distance (or angular offset) between thesensing elements 10,11.

FIG. 30 shows an embodiment of a measurement device 128 according to thepresent disclosure, which includes two additional layers 130,132 of thebiocompatible material. The layer 130 is disposed between the disc 8 andthe septum 5, and the layer 132 is disposed between the anchoring disc 9and the septum 5. In one example, the biocompatible material used in theadditional layers 130,132 is the same as the biocompatible material usedin the previously mentioned layers 116,124, though this need not be thecase in other examples. In one example, the sensing elements 10,11 inany of the embodiments of FIGS. 28-30 may be attached, tethered,stitched, bound, stapled, or adhered to the anchoring discs 8,9. Inanother example, the anchoring discs 8,9 are formed with the sensingelements 10,11 as an integral component within the discs 8,9.Furthermore, in one example, the sensing elements 10,11 are coupledwirelessly (including but not limited to Bluetooth technology) with theelectronics within the housing component 114 (e.g., the antenna 35 inFIG. 34). In another example, the sensing elements 10,11 are coupled viaone or more tethers with the electronics.

FIGS. 31 and 32 show another embodiment of a measurement device 134according to some examples. FIG. 32 is a side view, whereas FIG. 31shows the view from inside one of the atria adjacent to the atrialseptum 5 as seen from the direction of the arrow A in FIG. 32. Themeasurement device 134 has the anchoring disc 9 placed and attachedagainst the wall of the septum 5, and the disc 9 has an opening 136through which the tether 80 extends from the electronics housingcomponent 114 located behind the disc 9 into the atrium and ending atthe sensing element 11. In this example, instead of being located insidethe anchoring disc 9 or in the housing component 114, the sensingelement 11 is decoupled from the housing component 114 and located at alocation remote from the disc 9 and the housing component 114. Inanother example, the measurement device 134 can have a sensing elementin the disc and another sensing element in a remote location, such thatmore physiologic measurements can be performed using the additionalsensing element. In some examples, the tether 80 passes from an atriumto a ventricle, or a distal artery/vein, such that the sensing element11 performs physiologic measurements inside the ventricle.

The tether 80 can be covered partially or entirely by a layer 138 ofbiocompatible material. The layer 138 may be configured to promotetissue ingrowth and may be of sufficient length to help prevent thetether 80 from detaching from the surface of the septum 5. In anotherexample, instead of a single elongated layer 138, there may be multipleseparate layers covering the tether 80 at different sections thereof.Also, the sensing element 11 may be covered by a layer 142 ofbiocompatible material. In some examples, the layer 142 is optionallyconfigured similarly to the layer 116 referenced herein. In one example,similar to the embodiment shown in FIG. 30, the layer 132 ofbiocompatible material may be disposed between the sensing element 11and the septum 5.

FIG. 33 shows an embodiment in which the sensing element 11 issandwiched between two layers of biocompatible material, one of whichmay be the layer 142 previously mentioned. In the shown embodiment, thesensing element 11 is sandwiched between a bottom layer 144 and a toplayer, which in this case is the layer 142. The proximal layer 144 maybe positioned on the opposite side of the sensing element 11 from thelayer 142 such that the sensing element 11 does not directly come intocontact with a surface of the septum 5. In one example, the two layers142, 144 sandwiching the sensing element 11 cover the same surface areasuch that the top layer 142 completely covers the other layer 144 tolaminate the sensing element 11. In another example, the two layers 142,144 have different surface areas such that when they are overlapped withone another, one of the layers extends beyond the other layer. In oneexample, the two layers 142, 144 are made of the same biocompatiblematerial, whereas in another example, these layers may be made ofdifferent biocompatible materials.

In some examples, the right anchoring disc 8 is disposed in the rightatrium and the left anchoring disc 9 is disposed in the left atrium ofthe heart, such that electronics housing component 114 of themeasurement devices 112, 118, 122, 126, and 128 all extend into theright atrium of the heart while being substantially flush with the leftanchoring disc 9 in the left atrium. In other examples, the housingcomponent 114 may extend into the left atrium of the heart instead, suchthat the housing component 114 is substantially flush with the rightanchoring disc 8 in the right atrium. In some examples, because of theimbalance created between the protrusion on one end and the flushsurface on the other end of the housing component 114, one or morereinforcement struts 140 are employed to better support the housingcomponent 114 with one or both of the anchoring discs 8,9 to helpstabilize the implant to prevent unwanted device motion leading toincreased inflammatory response and tissue growth and to prevent thehousing component 114 from unwanted flexing and/or decoupling. FIG. 32shows the reinforcement struts 140 supporting the housing component 114against the anchoring disc 8. In some examples, the reinforcement strutsare nitinol wires or any other suitable material capable of stabilizingthe housing component 114.

In one example, one or more of the layers of biocompatible materialemployed is hydrophobic. In such examples, one or more of those layersmay be covered, coated, imbibed, or otherwise associated with ahydrophilic material such that the material is relatively more“echolucent”. For reference, a material that is echolucent allowspassage of ultrasonic waves therethrough such that the material does notinterfere with a sonogram, or ultrasound. A microporous membrane, suchas ePTFE, can also be modified to be echolucent by incorporating a vinylmonomer, such as PVA, polymerized within the pores of the membrane. Thehydrophilic material helps reduce or eliminate the presence of air inthe material, which in turn decreases the interference between the airand the ultrasound wave transmission. Other examples of hydrophiliclayers formed by applying a polymeric hydrophilic surfactant are taughtin U.S. Pat. No. 7,871,659 to Cook et al., assigned to Gore W. L. andAssociates Inc.

In some examples, the properties of one or more components of themeasuring device, including the anchoring discs, layers of biocompatiblematerial, and/or sensing elements, can be adjusted to better suit thephysiologic measurements being performed. For example, the sensingelement may be a flow sensor (e.g., ultrasound or other type of flowsensor), a temperature sensor, a pressure sensor, combinations thereof,or other sensor types as desired. Thus, the materials employed for thelayers of biocompatible material may be configured to promote orotherwise effectively transfer the mechanical/hydraulic response,thermal response, or other response to physiologic conditions in theportion of the heart, or other area of the body, being measured.

The sensing element may be highly thermally conductive, have a highlevel of hydraulic conductivity, or otherwise facilitate sensitivity tochanges in the environment being measured by the sensor. In addition tothe examples describing pressure measurements, the various measurementdevices may be configured to take temperature measurements to monitorcardiac function, for example. In some methods of monitoring, a coldbolus (e.g., fluid) may be introduced into the cardiac system and therate of temperature equalization may be used to determine cardiac outputwithin the heart, which is then measured by the thermometer. In suchinstances, the components may need to have thermally conductiveproperties to convey heat from the environment for sensing the changesin temperature.

The sensing element may be an oxygen saturation sensor which measuresthe diffusion characteristics of oxygen within the atrium. In suchinstances, the components may need to be sufficiently exposed to theenvironment to be able to detect such changes in the diffusioncharacteristics or be configured to effectively pass oxygen to thesensing components. These are just a few examples, and additionalexamples include adjusting other physical properties of the variouslayers and components of the measurement devices to improve sensorfunction.

Furthermore, in some examples, the sensing element or portions of themeasurement devices may incorporate flexible, printed electronicsincluding patterned traces deposited on one or more layers (e.g., toprovide an antenna, inductive power source, communication or signaltraces, or other functions. In one example, such patterned tracesconnect the sensing element to the housing component in lieu of thetether as part of the sensor assembly. In another example, suchpatterned traces are configured to provide sensing data, or otherwisetake measurements.

FIG. 35 illustrates a flow diagram of a method 200 for determining atreatment regimen for a patient according to some embodiments. In atleast some embodiments, the treatment regimen for the patient mayinclude maintaining a dosing regimen for the patient, increasing thedosing regimen for the patient, decreasing the dosing regimen for thepatient, changing the type of medication for the patient, confirmingand/or checking the heart waveform for the patient, and/or suggestingthe patient visit a medical professional for further testing and/ordiagnosis. In at least some embodiments, the treatment regimen for thepatient may be communicated to the patient by the monitoring system 72.In some embodiments, the embodiments described below for changing thetype of medication for the patient may be determined by a processingdevice using machine learning techniques.

For example, the method 200 may be implemented using one or moreelectronic devices, such as the monitoring system 72, using measurementdata received from, for example, the measurement device 41 or any of thesensor elements described herein. In at least some embodiments, themethod 200 may be used for patients with a history of LHF, right heartfailure (RHF), and/or primary pulmonary disorder to determine atreatment regimen guided by sensed left heart pressure measurements(e.g., left atrial pressure measurements) and/or right heart pressuremeasurements (e.g., right atrial pressure measurements).

In at least some embodiments, the method 200 (and/or algorithm 99) maybe used in a closed loop system (e.g., diuretic and/or vasodilator pump)to reduce the need to rely on patient compliance. Additionally, oralternatively, the method 200 (and/or algorithm 99) may be used withand/or incorporated into a therapy device (e.g., VAD) to adjust devicesettings (e.g., VAD RPMs) in addition to medications.

In some embodiments, the method 200 includes determining if the patienthas LHF, RHF, and/or primary pulmonary disorder condition (block 202).In at least some embodiments, a medical service professional may makethe determination based on one or more of patient history, familyhistory, a physical examination, chest radiography, electrocardiography,and/or the like. In embodiments, the method 200 may include inputtingand/or communicating the condition of the patient to one or more devices(block 204). For example, the condition may be input into the monitoringsystem 72.

The method 200 may also include determining one or more baseline heartpressure measurements (block 206). In at least some embodiments, thebaseline heart pressure measurements may be baseline left heart pressuremeasurements and/or baseline right heart pressure measurements. Forexample, the left heart pressure measurements may be left atrialpressure measurements (LAP) and the right heart pressure measurementsmay be right atrial pressure measurements (RAP). Additionally, oralternatively, other measurements may be sensed to represent the leftheart and/or right heart pressures. For example, surrogates for the leftheart pressure may be used. Exemplary surrogates for the left heartpressure may include, but are not limited to, the following: pulmonaryartery pressure (PAP), pulmonary arterial wedge pressure (PAWP),pulmonary artery systolic pressure (PASP), pulmonary artery diastolicpressure (PADP), right ventricular systolic pressure (RVSP), estimatedpulmonary artery diastolic pressure (ePAD), and left ventricularend-diastolic pressure (LVEDP). As another example, surrogates for theright heart pressure may be used. Exemplary surrogates for the rightheart pressure may include, but are not limited to, the following rightventricular end-diastolic pressure (RVEDP), central venous pressure(CVP), and jugular venous pulse (JVP).

In at least some embodiments, a Valsalva pressure measurement technique(remote or in office) may be used to re-calibrate the pressure sensorsif the pressure reading is suspect to sensor drift. The Valsalvatechnique allows the RAP and LAP to equalize with the exhale pressure ofa patient within seconds. If RAP and/or LAP are offset from the exhaledpressured, then a sensor baseline reading can be re-established in thesoftware. Due to the sensor location (atria), this technique willprevent the need for a right heart catheterization in order torecalibrate the sensors upon suspect of sensor drift.

In at least some embodiments, the baseline heart pressure measurementsmay be determined based on healthy heart pressure measurements. Forexample, a healthy heart may have left heart pressure measurements thatare approximately L₁ and right heart pressure measurements that areapproximately R₁. In embodiments, the baseline heart pressuremeasurements may be set to L₁ and R₁ +/− an appropriate variation. In atleast some embodiments, the variation may be +/−10%, 20%, etc. As such,the baseline heart pressure measurements may be set to L₁ and R₁ +/−10%,20%, etc.

Additionally, or alternatively, the baseline heart pressure measurementsmay be determined by a medical service provider based on the conditionof the patient. For example, a medical service provider may assignbaseline heart pressure measurements based on the condition of thepatient (e.g., LHR, RHF, and/or primary pulmonary disorder) and/or maytest the baseline heart pressure measurements of the patient in an acutesetting by performing various tests on the patient to determine, basedon the current condition of the patient, what normal heart pressuremeasurements would be. The baseline heart pressure measurements can thenbe input into and received by the monitoring system 72 (block 208).

The method 200 may also include sensing the LAP and/or the RAP afterbaseline pressures are established (block 210). In at least someembodiments, the LAP and/or the RAP are sensed at regular intervals. Forexample, the LAP and/or the RAP may be sensed every minute, every hour,every day, every week, every month, etc. In some embodiments, theright-side sensing element 10 and the left-side sensing element 11 maybe used to sense the RAP and/or the LAP, respectively. Once sensed, theLAP and/or the RAP may be sent to and received by the monitoring system72 (block 212).

The method 200 may further include determining whether the sensed LAPand/or the sensed RAP vary from the baseline heart pressure measurements(block 214). For example, the monitoring system 72 may compare the LAPand/or the RAP sensed in block 210 with the baseline measurementsestablished in block 208. The monitoring system 72 can then determinewhether the LAP and/or RAP are below, at, or above the baseline heartpressure measurements established in block 208. For example, if the LAPand/or the RAP are within a threshold of the baseline heart pressuremeasurements, then the method 200 may proceed back to block 210 andcontinue to monitor the LAP and/or the RAP. Alternatively, if the LAPand/or the RAP are above or below the baseline heart pressuremeasurements by a threshold, then the method 200 may proceed to block216.

In at least some embodiments, the threshold may be a percentagedifference of the baseline heart pressure measurements. In someembodiments, the percentage difference may be input into the monitoringsystem 72. For example, the threshold may be +/−5%, +/−10%, +/−15%,+/−20%, +/−25%, etc. of the baseline heart pressure measurements. And,once a percentage threshold is selected and input into the monitoringsystem 72, if the sensed LAP and/or the sensed RAP are within theselected percentage of the baseline heart pressure measurements, thenthe method 200 may proceed to block 210. Alternatively, if the sensedLAP and/or the sensed RAP differ by the selected percentage or differ bymore than the selected percentage from the baseline heart pressuremeasurements, then the method 200 may proceed to block 216.

In at least some other embodiments, the threshold may be a constant. Insome embodiments, the percentage difference may be input into themonitoring system 72. For example, the threshold may be x₁ millimetersof mercury (mmHg). And, if the sensed LAP and/or the sensed RAP arewithin x₁ of the baseline heart pressure measurements, then the method200 may proceed to block 210. Alternatively, if the sensed LAP and/orthe sensed RAP differ by x₁ or differ by more than x₁ than the baselineheart pressure measurements, then the method 200 may proceed to block216.

Additionally, or alternatively, the method 200 may also includedetermining a trend of the sensed LAP and/or the sensed RAP. Forexample, the monitoring system 72 may determine whether the pressurevalues are increasing, decreasing, or staying steady as an additionalinput into the overall assessment.

In the event the method 200 proceeds to block 216, the method 200proceeds to appropriate figure of FIGS. 36-42, based on the patient'scondition. That is, if the method 200 determines the patient has onlyLHF at block 202, then the method 200 proceeds to tables 300, 350illustrated in FIG. 36. If the method 200 determines the patient hasonly RHF at block 202, then the method 200 proceeds to table 400, 450illustrated in FIG. 37. If the method 200 determines the patient hasonly primary pulmonary disorder at block 202, then the method 200proceeds to table 500, 550 illustrated in FIG. 38. If the method 200determines the patient has only LHF and RHF at block 202, then themethod 200 proceeds to table 600, 650 illustrated in FIG. 39. If themethod 200 determines the patient has only LHF and primary pulmonarydisorder at block 202, then the method 200 proceeds to table 700, 750illustrated in FIG. 40. If the method 200 determines the patient hasonly RHF and primary pulmonary disorder at block 202, then the method200 proceeds to table 800, 850 illustrated in FIG. 41. And, if themethod 200 determines the patient has LHF, RHF, and primary pulmonarydisorder at block 202, then the method 200 proceeds to table 900, 950illustrated in FIG. 42. Once the appropriate table is referenced, themethod 200 determines a treatment regimen for the patient based on therecommended treatment regimen from the table using the sensed LAP and/orthe sensed RAP (block 218). In at least some embodiments, the monitoringsystem 72 may reference the appropriate table of the tables illustratedin FIGS. 36-42 and instruct (via a notification and/or othercommunication) the patient and/or medical professional to follow thetreatment regimen proposed by the appropriate table. Once the treatmentregimen is determined, administered, and/or communicated at block 218,the method 200 may return to block 210 to sense the LAP and/or RAP andcontinue through method 200 to determine whether the treatment regimenis effective. In at least some embodiments treatments may include, butare not limited to, diagnosis, medication titrations, advanced therapy,IV medications, lifestyle changes, intra-atrial shunts, valverepair/replace, ICDs, CRTs, and ablation. Exemplary medicationtitrations may include, but are not limited to, vasodilators, diuretics,pulmonary vasodilators, neurohormonal antagonists, beta blockers, andinotropes. Exemplary advanced therapies may include, but are not limitedto, implanting a ventricular assist device (VAD), a transplant, or both.Exemplary lifestyle changes may include, but are not limited to, achange in diet, increased activity, or both.

The method 200 may be adjusted to be more specific in terms of how mucha pharmacological, or medication regimen needs to be increased orreduced, which can be varied based on how much the LAP and RAP are aboveor below the baseline levels. This may be done by implementing anothertable or set of guidelines within the tables illustrated in FIGS. 36-42that indicates the amount of medication to be administered (e.g., sothat a treatment dosage regimen may be adjusted for a patient withoutrequiring direct medical service provider intervention). Furthermore, toinform the patient on which medication to choose and its dosage, thetype of medication (e.g. diuretic or vasodilator) that needs to beadministered and the dosage thereof can be displayed on, for example,the screen of a computer or a display of a smart device used by thepatient.

The measurement data and associated monitoring and treatment methodologyis not necessarily limited to LAP and RAP measurements. In someexamples, additional or alternative locations (e.g., pulmonary arteries,ventricles, pulmonary veins, aorta, and others) and/or additional oralternative metrics (e.g., temperature and/or oxygen saturation) may beutilized in implementing a monitoring and treatment method such as themethod 200.

As explained above, the method 200 may be performed manually or may bepartially or completely automated using any device capable of receivingand processing the measurement data from the measurement device 41. Forexample, the method 200 may be implemented entirely in the monitoringsystem 72 (e.g., such as a smart device), which performs all thecomparisons, calculations, and determinations after receiving the LAPand RAP measurement data from the measurement system 41. In someexamples, the method 200 may be implemented partially in the monitoringsystem 72 and partially in the communications relay 70 which may includea processing unit to receive the LAP and RAP measurement data from thesensors, determine whether the LAP and RAP are above/at/below normallevel and decreasing/steady/increasing, then relay this information tothe remote device 72 to perform the rest of the method. In yet anotherexample, the subcutaneous implant 83 may be programmed to perform aportion or the entirety of the method 200.

In still further examples, the method 200 may be implemented in a devicewith a user interface allowing the patient to administer medicationsaccording to the results of the method 200. The method 200 may also beimplemented in the medical service providers' electronic health record(EHR) or electronic medical record (EMR) systems which keep track of thenecessary records of each patient. As such, the EHR or EMR systems mayuse local or remote database to access, among other things, thepatient's history of LHF or RHF and whether the medical serviceproviders have deemed the patient to be at a risk of such failure. Theresulting data from the method 200 may be displayed on a dashboard ofthe user interface with multiple options for the user (e.g. patient andmedical service providers), which may include: LAP and RAP averages,trend arrows, line graphs over time, and waveforms, as well as a historyof the medications taken by the patient, etc. The dashboard may also beconfigured such that the user can first pull up the most meaningfulinformation, such as the averages and trends, and a more detailedanalysis can then be displayed, such as the waveforms. This may beimplemented by organizing the multiple options in a hierarchical mannerbased on the importance of each option. In one example, thishierarchical order of the options is customizable according to theuser's preference, such that the most preferred information can bepulled up first.

Referring to FIG. 36, an exemplary diagnostic regimen lookup table 300and an exemplary treatment regimen lookup table 350 are illustrated fora patient diagnosed with the condition of LHF. In particular, the table300 has three columns 302, 304, 306 and three rows 308, 310, 312 andeach cell illustrates a pathology of the patient based on correspondingsensed heart pressure measurements for the patient. Similarly, the table350 has three columns 352, 354, 356 and three rows 358, 360, 362 andeach cell illustrates a treatment regimen for the patient based oncorresponding sensed pressure measurements and the identified pathologyin table 300. That is, columns 302, 352 pertain to the RAP sensed atblock 210 (of FIG. 35) being lower than the baseline RAP determined atblock 206 (of FIG. 35) by a threshold. Columns 304, 354 pertain to theRAP sensed at block 210 (of FIG. 35) being within a threshold of thebaseline RAP determined at block 206 (of FIG. 35). Columns 306, 356pertains to the RAP sensed at block 210 (of FIG. 35) being greater thanthe baseline RAP determined at block 206 (of FIG. 35) by a threshold.Rows 308, 358 pertain to the LAP sensed at block 210 (of FIG. 35) beinghigher than the baseline LAP determined at block 206 (of FIG. 35) by athreshold. Rows 310, 360 pertain to the LAP sensed at block 210 (of FIG.35) being within a threshold of the baseline LAP determined at block 206(of FIG. 35). And, rows 312, 362 pertain to the LAP sensed at block 210(of FIG. 35) being less than the baseline LAP determined at block 206(of FIG. 35) by a threshold.

Referring to columns 302, 352, the sensed RAP is lower than the baselineRAP by a threshold. In the event the sensed LAP is higher than thebaseline LAP by a threshold, which corresponds to rows 308, 358, then itis likely the systemic vascular resistance (SVR) of the patient hasincreased so the treatment regimen for the patient is to increase thevasodilator dosing regimen of the patient according to table 350. Asanother example and still referring to columns 302, 352, if the sensedLAP is within a threshold of the baseline LAP, which corresponds to rows310, 360, then it is likely the SVR of the patient has increased and theintravascular volume of the patient has decreased, so the vasodilatordosing regimen of the patient is increased while the diuretic dosingregimen of the patient is decreased. As even another example and stillreferring to columns 302, 352, if the sensed LAP is lower than thebaseline LAP by a threshold, which corresponds to rows 312, 362, then itis likely the intravascular volume of the patient has decreased, and thecorresponding treatment regimen indicated in table 350 is to decreasethe diuretic dosing regimen of the patient.

Referring to columns 304, 354, the sensed RAP is within a threshold ofthe baseline RAP. In the event the sensed LAP is higher than thebaseline LAP by a threshold, then it is likely the SVR of the patienthas increased and the intravascular volume of the patient has increased.In this case, the vasodilator dosing regimen of the patient isincreased, and the diuretic dosing regimen of the patient is increased.As another example and still referring to columns 304, 354, if thesensed LAP is within a threshold of the baseline LAP, then it is likelythe dosing regimen of the patient is effective, and the currenttreatment regimen is maintained. As even another example and stillreferring to columns 304, 354, if the sensed LAP is lower than thebaseline LAP by a threshold, then it is likely the pulmonary vascularresistance (PVR) of the patient has increased, or the patient isexperiencing RHF and the intravascular volume of the patient hasdecreased. In this case, the monitoring system 72 may suggest thepatient visit a medical professional for further testing and/ordiagnosis.

Referring to columns 306, 356, the sensed RAP is greater than thebaseline RAP by a threshold. In the event the sensed LAP is higher thanthe baseline LAP by a threshold, then it is likely the intravascularvolume of the patient has increased, so the diuretic dosing regimen ofthe patient is increased. As another example and still referring tocolumns 306, 356, if the sensed LAP is within a threshold of thebaseline LAP, then the patient is likely experiencing RHF and increasedintravascular volume, or the PVR of the patient has increased and theintravascular volume of the patient has increased. In this case, themonitoring system 72 may suggest the patient visit a medicalprofessional for further testing and/or diagnosis. Additionally, oralternatively, the diagnosis may be performed automatically by themonitoring system 72. As even another example and still referring tocolumns 306, 356, if the sensed LAP is lower than the baseline LAP by athreshold, then it is likely the patient is experiencing RHF. In thiscase, the monitoring system 72 may suggest the patient visit a medicalprofessional for further testing and/or diagnosis. Additionally, oralternatively, the diagnosis may be performed automatically by themonitoring system 72. For any of these dosing regimen changes, themonitoring system 72 may send a notification and/or send correspondinginstructions to a therapy device.

Referring to FIG. 37, an exemplary diagnostic regimen lookup table 400and an exemplary treatment regimen lookup table 450 are illustrated fora patient diagnosed with the condition of RHF. In particular, the table400 has three columns 402, 404, 406 and three rows 408, 410, 412 andeach cell illustrates a pathology of the patient based on correspondingsensed heart pressure measurements for the patient. Similarly, the table450 has three columns 452, 454, 456 and three rows 458, 460, 462 andeach cell illustrates a treatment regimen for the patient based oncorresponding sensed pressure measurements and the identified pathologyin table 400. That is, columns 402, 452 pertain to the RAP sensed atblock 210 (of FIG. 35) being lower than the baseline RAP determined atblock 206 (of FIG. 35) by a threshold. Columns 404, 454 pertain to theRAP sensed at block 210 (of FIG. 35) being within a threshold of thebaseline RAP determined at block 206 (of FIG. 35). Columns 406, 456pertains to the RAP sensed at block 210 (of FIG. 35) being greater thanthe baseline RAP determined at block 206 (of FIG. 35) by a threshold.Rows 408, 458 pertain to the LAP sensed at block 210 (of FIG. 35) beinghigher than the baseline LAP determined at block 206 (of FIG. 35) by athreshold. Rows 410, 460 pertain to the LAP sensed at block 210 (of FIG.35) being within a threshold of the baseline LAP determined at block 206(of FIG. 35). And, rows 412, 462 pertain to the LAP sensed at block 210(of FIG. 35) being less than the baseline LAP determined at block 206(of FIG. 35) by a threshold.

Referring to columns 402, 452, the sensed RAP is lower than the baselineRAP by a threshold. In the event the sensed LAP is higher than thebaseline LAP by a threshold, which corresponds to rows 408, 458, then itis likely the patient is experiencing LHF. In this case, the monitoringsystem 72 may suggest the patient visit a medical professional forfurther testing and/or diagnosis. Additionally, or alternatively, thediagnosis may be performed automatically by the monitoring system 72. Asanother example and still referring to columns 402, 452, if the sensedLAP is within a threshold of the baseline LAP, which corresponds to rows410, 460, then it is likely the patient is experiencing LHF and theintravascular volume of the patient has decreased. In this case, themonitoring system 72 may suggest the patient visit a medicalprofessional for further testing and/or diagnosis. Additionally, oralternatively, the diagnosis may be performed automatically by themonitoring system 72. As even another example and still referring tocolumns 402, 452, if the sensed LAP is lower than the baseline LAP by athreshold, which corresponds to rows 412, 462, then it is likely theintravascular volume of the patient has decreased, and the correspondingtreatment regimen is to decrease the diuretic dosing regimen of thepatient

Referring to columns 404, 454, the sensed RAP is within a threshold ofthe baseline RAP. In the event the sensed LAP is higher than thebaseline LAP by a threshold, then it is likely the patient isexperiencing LHF and increased intravascular volume. In this case, themonitoring system 72 may suggest the patient visit a medicalprofessional for further testing and/or diagnosis. Additionally, oralternatively, the diagnosis may be performed automatically by themonitoring system 72. As another example and still referring to columns404, 454, if the sensed LAP is within a threshold of the baseline LAP,then it is likely the dosing regimen of the patient is effective, andthe current treatment regimen is maintained. As even another example andstill referring to columns 404, 454, if the sensed LAP is lower than thebaseline LAP by a threshold, then it is likely the patient's RHF isgetting worse and the intravascular volume of the patient has decreased.In this case, the corresponding treatment regimen is to increase thepulmonary vasodilators treatment regimen and decrease the diuretictreatment regimen.

Referring to columns 406, 456, the sensed RAP is greater than thebaseline RAP by a threshold. In the event the sensed LAP is higher thanthe baseline LAP by a threshold, then it is likely the intravascularvolume of the patient has increased so the corresponding treatmentregimen indicated in table 450 is to increase the diuretic dosingregimen of the patient. As another example and still referring tocolumns 406, 456, if the sensed LAP is within a threshold of thebaseline LAP, then the patient's RHF is likely worsening and theintravascular volume of the patient has increased. In this case, thecorresponding dosing regimen indicated in table 450 is to increasepulmonary vasodilators and increase diuretics. As even another exampleand still referring to columns 406, 456, if the sensed LAP is lower thanthe baseline LAP by a threshold, then it is likely the patient's RHF isworsening. In this case, the corresponding treatment regimen indicatedin table 450 is to increase the pulmonary vasodilators. For any of thesedosing regimen changes, the monitoring system 72 may send a notificationand/or send corresponding instructions to a therapy device.

Referring to FIG. 38, an exemplary diagnostic regimen lookup table 500and an exemplary treatment regimen lookup table 550 are illustrated fora patient diagnosed with the condition of primary pulmonary disorder. Inparticular, the table 500 has three columns 502, 504, 506 and three rows508, 510, 512 and each cell illustrates a pathology of the patient basedon corresponding sensed heart pressure measurements for the patient.Similarly, the table 550 has three columns 552, 554, 556 and three rows558, 560, 562 and each cell illustrates a treatment regimen for thepatient based on corresponding sensed pressure measurements and theidentified pathology in Table 500. That is, columns 502, 552 pertain tothe RAP sensed at block 210 (of FIG. 35) being lower than the baselineRAP determined at block 206 (of FIG. 35) by a threshold. Columns 504,554 pertain to the RAP sensed at block 210 (of FIG. 35) being within athreshold of the baseline RAP determined at block 206 (of FIG. 35).Columns 506, 556 pertains to the RAP sensed at block 210 (of FIG. 35)being greater than the baseline RAP determined at block 206 (of FIG. 35)by a threshold. Rows 508, 558 pertain to the LAP sensed at block 210 (ofFIG. 35) being higher than the baseline LAP determined at block 206 (ofFIG. 35) by a threshold. Rows 510, 560 pertain to the LAP sensed atblock 210 (of FIG. 35) being within a threshold of the baseline LAPdetermined at block 206 (of FIG. 35). And, rows 512, 562 pertain to theLAP sensed at block 210 (of FIG. 35) being less than the baseline LAPdetermined at block 206 (of FIG. 35) by a threshold.

Referring to columns 502, 552, the sensed RAP is lower than the baselineRAP by a threshold. In the event the sensed LAP is higher than thebaseline LAP by a threshold, which corresponds to rows 508, 558, then itis likely the patient is experiencing LHF. In this case, the monitoringsystem 72 may suggest the patient visit a medical professional forfurther testing and/or diagnosis. Additionally, or alternatively, thediagnosis may be performed automatically by the monitoring system 72. Asanother example and still referring to columns 502, 552, if the sensedLAP is within a threshold of the baseline LAP, which corresponds to rows510, 560, then it is likely the patient is experiencing LHF and theintravascular volume of the patient has decreased. In this case, themonitoring system 72 may suggest the patient visit a medicalprofessional for further testing and/or diagnosis. Additionally, oralternatively, the diagnosis may be performed automatically by themonitoring system 72. As even another example and still referring tocolumns 502, 552, if the sensed LAP is lower than the baseline LAP by athreshold, which corresponds to rows 512, 562, then it is likely theintravascular volume of the patient has decreased, and the correspondingtreatment regimen is to decrease the diuretic dosing regimen of thepatient.

Referring to columns 504, 554, the sensed RAP is within a threshold ofthe baseline RAP. In the event the sensed LAP is higher than thebaseline LAP by a threshold, then it is likely the patient isexperiencing LHF and increased intravascular volume. In this case, themonitoring system 72 may suggest the patient visit a medicalprofessional for further testing and/or diagnosis. Additionally, oralternatively, the diagnosis may be performed automatically by themonitoring system 72. As another example and still referring to columns504, 554, if the sensed LAP is within a threshold of the baseline LAP,then it is likely the dosing regimen of the patient is effective, andthe current treatment regimen is maintained. As even another example andstill referring to columns 504, 554, if the sensed LAP is lower than thebaseline LAP by a threshold, then it is likely the patient's PVR isworsening. In this case, the corresponding treatment regimen is toincrease the pulmonary vasodilators treatment regimen.

Referring to columns 506, 556, the sensed RAP is greater than thebaseline RAP by a threshold. In the event the sensed LAP is higher thanthe baseline LAP by a threshold, then it is likely the intravascularvolume of the patient has increased so the corresponding treatmentregimen indicated in table 550 is to increase the diuretic dosingregimen of the patient. As another example and still referring tocolumns 506, 556, if the sensed LAP is within a threshold of thebaseline LAP, then the patient is experiencing RHF and the intravascularvolume of the patient has increased, or the patients PVR is worseningand the intravascular volume of the patient has increased. In this case,the corresponding dosing regimen indicated in table 550 is to increasepulmonary vasodilators and increase diuretics. As even another exampleand still referring to columns 506, 556, if the sensed LAP is lower thanthe baseline LAP by a threshold, then it is likely the patient isexperiencing RHF. In this case, the monitoring system 72 may suggest thepatient visit a medical professional for further testing and/ordiagnosis. Additionally, or alternatively, the diagnosis may beperformed automatically by the monitoring system 72. For any of thesedosing regimen changes, the monitoring system 72 may send a notificationand/or send corresponding instructions to a therapy device.

Referring to FIG. 39, an exemplary diagnostic regimen lookup table 600and an exemplary treatment regimen lookup table 650 are illustrated fora patient diagnosed with the condition of LHF and RHF. In particular,the table 600 has three columns 602, 604, 606 and three rows 608, 610,612 and each cell illustrates a pathology of the patient based oncorresponding sensed heart pressure measurements for the patient.Similarly, the table 650 has three columns 652, 654, 656 and three rows658, 660, 662 and each cell illustrates a treatment regimen for thepatient based on corresponding sensed pressure measurements and theidentified pathology in Table 600. That is, columns 602, 652 pertain tothe RAP sensed at block 210 (of FIG. 35) being lower than the baselineRAP determined at block 206 (of FIG. 35) by a threshold. Columns 604,654 pertain to the RAP sensed at block 210 (of FIG. 35) being within athreshold of the baseline RAP determined at block 206 (of FIG. 35).Columns 606, 656 pertains to the RAP sensed at block 210 (of FIG. 35)being greater than the baseline RAP determined at block 206 (of FIG. 35)by a threshold. Rows 608, 658 pertain to the LAP sensed at block 210 (ofFIG. 35) being higher than the baseline LAP determined at block 206 (ofFIG. 35) by a threshold. Rows 610, 660 pertain to the LAP sensed atblock 210 (of FIG. 35) being within a threshold of the baseline LAPdetermined at block 206 (of FIG. 35). And, rows 612, 662 pertain to theLAP sensed at block 210 (of FIG. 35) being less than the baseline LAPdetermined at block 206 (of FIG. 35) by a threshold.

Referring to columns 602, 652, the sensed RAP is lower than the baselineRAP by a threshold. In the event the sensed LAP is higher than thebaseline LAP by a threshold, which corresponds to rows 608, 658, then itis likely the SVR of the patient has increased so the treatment regimenfor the patient is to increase the vasodilator dosing regimen of thepatient, as indicated in table 650. As another example and stillreferring to columns 602, 652, if the sensed LAP is within a thresholdof the baseline LAP, which corresponds to rows 610, 660, then it islikely the SVR of the patient has increased and the intravascular volumeof the patient has decreased, so the corresponding treatment regimenindicated in table 650 is to increase the vasodilator dosing regimen ofthe patient while decreasing the diuretic dosing regimen of the patient.As even another example and still referring to columns 602, 652, if thesensed LAP is lower than the baseline LAP by a threshold, whichcorresponds to rows 612, 662, then it is likely the intravascular volumeof the patient has decreased, and the corresponding treatment regimenindicated in table 650 is to decrease the diuretic dosing regimen of thepatient.

Referring to columns 604, 654, the sensed RAP is within a threshold ofthe baseline RAP. In the event the sensed LAP is higher than thebaseline LAP by a threshold, then it is likely the SVR of the patienthas increased and the intravascular volume of the patient has increased.In this case, the vasodilator dosing regimen of the patient isincreased, and the diuretic dosing regimen of the patient is increased.As another example and still referring to columns 604, 654, if thesensed LAP is within a threshold of the baseline LAP, then it is likelythe dosing regimen of the patient is effective, and the currenttreatment regimen is maintained. As even another example and stillreferring to columns 604, 654, if the sensed LAP is lower than thebaseline LAP by a threshold, then it is likely the patient's RHF isworsening and the intravascular volume of the patient has decreased. Inthis case, the treatment regimen indicated in table 650 is to increasethe pulmonary vasodilators dosing regimen and decrease the diureticdosing regimen.

Referring to columns 606, 656, the sensed RAP is greater than thebaseline RAP by a threshold. In the event the sensed LAP is higher thanthe baseline LAP by a threshold, then it is likely the intravascularvolume of the patient has increased so the corresponding treatmentregimen indicated in table 650 is to increase the diuretic dosingregimen of the patient. As another example and still referring tocolumns 606, 656, if the sensed LAP is within a threshold of thebaseline LAP, then the patient's RHF is likely worsening and theintravascular volume of the patient has increased. In this case, thecorresponding dosing regimen indicated in table 650 is to increasepulmonary vasodilators and increase diuretics. As even another exampleand still referring to columns 606, 656, if the sensed LAP is lower thanthe baseline LAP by a threshold, then it is likely the patient's RHF isworsening. In this case, the corresponding treatment regimen indicatedin table 650 is to increase the pulmonary vasodilators. For any of thesedosing regimen changes, the monitoring system 72 may send a notificationand/or send corresponding instructions to a therapy device.

Referring to FIG. 40, an exemplary diagnostic regimen lookup table 700and an exemplary treatment regimen lookup table 750 are illustrated fora patient diagnosed with the condition of LHF and primary pulmonarydisorder. In particular, the table 700 has three columns 702, 704, 706and three rows 708, 710, 712 and each cell illustrates a pathology ofthe patient based on corresponding sensed heart pressure measurementsfor the patient. Similarly, the table 750 has three columns 752, 754,756 and three rows 758, 760, 762 and each cell illustrates a treatmentregimen for the patient based on corresponding sensed pressuremeasurements and the identified pathology in Table 700. That is, columns702, 752 pertain to the RAP sensed at block 210 (of FIG. 35) being lowerthan the baseline RAP determined at block 206 (of FIG. 35) by athreshold. Columns 704, 754 pertain to the RAP sensed at block 210 (ofFIG. 35) being within a threshold of the baseline RAP determined atblock 206 (of FIG. 35). Columns 706, 756 pertains to the RAP sensed atblock 210 (of FIG. 35) being greater than the baseline RAP determined atblock 206 (of FIG. 35) by a threshold. Rows 708, 758 pertain to the LAPsensed at block 210 (of FIG. 35) being higher than the baseline LAPdetermined at block 206 (of FIG. 35) by a threshold. Rows 710, 760pertain to the LAP sensed at block 210 (of FIG. 35) being within athreshold of the baseline LAP determined at block 206 (of FIG. 35). And,rows 712, 762 pertain to the LAP sensed at block 210 (of FIG. 35) beingless than the baseline LAP determined at block 206 (of FIG. 35) by athreshold.

Referring to columns 702, 752, the sensed RAP is lower than the baselineRAP by a threshold. In the event the sensed LAP is higher than thebaseline LAP by a threshold, which corresponds to rows 708, 758, then itis likely the SVR of the patient has increased so the treatment regimenfor the patient is to increase the vasodilator dosing regimen of thepatient, as indicated in table 750. As another example and stillreferring to columns 702, 752, if the sensed LAP is within a thresholdof the baseline LAP, which corresponds to rows 710, 760, then it islikely the SVR of the patient has increased and the intravascular volumeof the patient has decreased, so the corresponding treatment regimenindicated in table 750 is to increase the vasodilator dosing regimen ofthe patient while decreasing the diuretic dosing regimen of the patient.As even another example and still referring to columns 702, 752, if thesensed LAP is lower than the baseline LAP by a threshold, whichcorresponds to rows 712, 762, then it is likely the intravascular volumeof the patient has decreased, and the corresponding treatment regimenindicated in table 750 is to decrease the diuretic dosing regimen of thepatient.

Referring to columns 704, 754, the sensed RAP is within a threshold ofthe baseline RAP. In the event the sensed LAP is higher than thebaseline LAP by a threshold, then it is likely the SVR of the patienthas increased and the intravascular volume of the patient has increased.In this case, the corresponding treatment regimen indicated in table 750is to increase the vasodilator dosing regimen for the patient andincrease the diuretic dosing regimen of the patient. As another exampleand still referring to columns 704, 754, if the sensed LAP is within athreshold of the baseline LAP, then it is likely the dosing regimen ofthe patient is effective, and the current treatment regimen ismaintained. As even another example and still referring to columns 704,754, if the sensed LAP is lower than the baseline LAP by a threshold,then it is likely the patient's PVR is worsening. In this case, thetreatment regimen indicated in table 750 is to increase the pulmonaryvasodilators dosing regimen for the patient.

Referring to columns 706, 756, the sensed RAP is greater than thebaseline RAP by a threshold. In the event the sensed LAP is higher thanthe baseline LAP by a threshold, then it is likely the intravascularvolume of the patient has increased so the corresponding treatmentregimen indicated in table 750 is to increase the diuretic dosingregimen of the patient. As another example and still referring tocolumns 706, 756, if the sensed LAP is within a threshold of thebaseline LAP, then the patient's PVR is likely worsening and theintravascular volume of the patient has increased. In this case, thecorresponding dosing regimen indicated in table 750 is to increasepulmonary vasodilators and increase diuretics. As even another exampleand still referring to columns 706, 756, if the sensed LAP is lower thanthe baseline LAP by a threshold, then it is likely the patient isexperiencing RHF. In this case, the monitoring system 72 may suggest thepatient visit a medical professional for further testing and/ordiagnosis. Additionally, or alternatively, the diagnosis may beperformed automatically by the monitoring system 72. For any of thesedosing regimen changes, the monitoring system 72 may send a notificationand/or send corresponding instructions to a therapy device.

Referring to FIG. 41, an exemplary diagnostic regimen lookup table 800and an exemplary treatment regimen lookup table 850 are illustrated fora patient diagnosed with the condition of RHF and primary pulmonarydisorder. In particular, the table 800 has three columns 802, 804, 806and three rows 808, 810, 812 and each cell illustrates a pathology ofthe patient based on corresponding sensed heart pressure measurementsfor the patient. Similarly, the table 850 has three columns 852, 854,856 and three rows 858, 860, 862 and each cell illustrates a treatmentregimen for the patient based on corresponding sensed pressuremeasurements and the identified pathology in Table 800. That is, columns802, 852 pertain to the RAP sensed at block 210 (of FIG. 35) being lowerthan the baseline RAP determined at block 206 (of FIG. 35) by athreshold. Columns 804, 854 pertain to the RAP sensed at block 210 (ofFIG. 35) being within a threshold of the baseline RAP determined atblock 206 (of FIG. 35). Columns 806, 856 pertains to the RAP sensed atblock 210 (of FIG. 35) being greater than the baseline RAP determined atblock 206 (of FIG. 35) by a threshold. Rows 808, 858 pertain to the LAPsensed at block 210 (of FIG. 35) being higher than the baseline LAPdetermined at block 206 (of FIG. 35) by a threshold. Rows 810, 860pertain to the LAP sensed at block 210 (of FIG. 35) being within athreshold of the baseline LAP determined at block 206 (of FIG. 35). And,rows 812, 862 pertain to the LAP sensed at block 210 (of FIG. 35) beingless than the baseline LAP determined at block 206 (of FIG. 35) by athreshold.

Referring to columns 802, 852, the sensed RAP is lower than the baselineRAP by a threshold. In the event the sensed LAP is higher than thebaseline LAP by a threshold, which corresponds to rows 808, 858, then itis likely the patient is experiencing LHF. In this case, the monitoringsystem 72 may suggest the patient visit a medical professional forfurther testing and/or diagnosis. Additionally, or alternatively, thediagnosis may be performed automatically by the monitoring system 72. Asanother example and still referring to columns 802, 852, if the sensedLAP is within a threshold of the baseline LAP, which corresponds to rows810, 860, then it is likely the patient is experiencing LHF and theintravascular volume of the patient has decreased. In this case, themonitoring system 72 may suggest the patient visit a medicalprofessional for further testing and/or diagnosis. Additionally, oralternatively, the diagnosis may be performed automatically by themonitoring system 72. As even another example and still referring tocolumns 802, 852, if the sensed LAP is lower than the baseline LAP by athreshold, which corresponds to rows 812, 862, then it is likely theintravascular volume of the patient has decreased, and the correspondingtreatment regimen is to decrease the diuretic dosing regimen of thepatient.

Referring to columns 804, 854, the sensed RAP is within a threshold ofthe baseline RAP. In the event the sensed LAP is higher than thebaseline LAP by a threshold, then it is likely the patient isexperiencing LHF and increased intravascular volume. In this case, themonitoring system 72 may suggest the patient visit a medicalprofessional for further testing and/or diagnosis. Additionally, oralternatively, the diagnosis may be performed automatically by themonitoring system 72. As another example and still referring to columns804, 854, if the sensed LAP is within a threshold of the baseline LAP,then it is likely the dosing regimen of the patient is effective, andthe current treatment regimen is maintained. As even another example andstill referring to columns 804, 854, if the sensed LAP is lower than thebaseline LAP by a threshold, then it is likely the patient's PVR isworsening or the patient's RHF is worsening and the intravascular volumeof the patient has increased. In this case, the corresponding treatmentregimen illustrated in table 850 is to increase the pulmonaryvasodilators treatment regimen and decrease the diuretic treatmentregimen for the patient.

Referring to columns 806, 856, the sensed RAP is greater than thebaseline RAP by a threshold. In the event the sensed LAP is higher thanthe baseline LAP by a threshold, then it is likely the intravascularvolume of the patient has increased so the corresponding treatmentregimen indicated in table 850 is to increase the diuretic dosingregimen of the patient. As another example and still referring tocolumns 806, 856, if the sensed LAP is within a threshold of thebaseline LAP, then the patient's RHF is likely worsening and theintravascular volume of the patient has increased or the patient's PVRis worsening and the intravascular volume of the patient has increased.In this case, the corresponding dosing regimen indicated in table 850 isto increase pulmonary vasodilators and increase diuretics. As evenanother example and still referring to columns 806, 856, if the sensedLAP is lower than the baseline LAP by a threshold, then it is likely thepatient's RHF is worsening. In this case, the corresponding treatmentregimen indicated in table 850 is to increase the pulmonaryvasodilators. For any of these dosing regimen changes, the monitoringsystem 72 may send a notification and/or send corresponding instructionsto a therapy device.

Referring to FIG. 42, an exemplary diagnostic regimen lookup table 900and an exemplary treatment regimen lookup table 950 for a patientdiagnosed with the condition of LHF, RHF, and primary pulmonary disorderare illustrated. In particular, the table 900 has three columns 902,904, 906 and three rows 908, 910, 912 and each cell illustrates apathology of the patient based on corresponding sensed heart pressuremeasurements for the patient. Similarly, the table 950 has three columns952, 954, 956 and three rows 958, 960, 962 and each cell illustrates atreatment regimen for the patient based on corresponding sensed pressuremeasurements and the identified pathology in Table 900. That is, columns902, 952 pertain to the RAP sensed at block 210 (of FIG. 35) being lowerthan the baseline RAP determined at block 206 (of FIG. 35) by athreshold. Columns 904, 954 pertain to the RAP sensed at block 210 (ofFIG. 35) being within a threshold of the baseline RAP determined atblock 206 (of FIG. 35). Columns 906, 956 pertains to the RAP sensed atblock 210 (of FIG. 35) being greater than the baseline RAP determined atblock 206 (of FIG. 35) by a threshold. Rows 908, 958 pertain to the LAPsensed at block 210 (of FIG. 35) being higher than the baseline LAPdetermined at block 206 (of FIG. 35) by a threshold. Rows 910, 960pertain to the LAP sensed at block 210 (of FIG. 35) being within athreshold of the baseline LAP determined at block 206 (of FIG. 35). And,rows 912, 962 pertain to the LAP sensed at block 210 (of FIG. 35) beingless than the baseline LAP determined at block 206 (of FIG. 35) by athreshold.

Referring to columns 902, 952, the sensed RAP is lower than the baselineRAP by a threshold. In the event the sensed LAP is higher than thebaseline LAP by a threshold, which corresponds to rows 908, 958, then itis likely the SVR of the patient has increased so the treatment regimenfor the patient is to increase the vasodilator dosing regimen of thepatient, as indicated in table 950. As another example and stillreferring to columns 902, 952, if the sensed LAP is within a thresholdof the baseline LAP, which corresponds to rows 910, 960, then it islikely the SVR of the patient has increased and the intravascular volumeof the patient has decreased, so the corresponding treatment regimenindicated in table 950 is to increase the vasodilator dosing regimen ofthe patient while decreasing the diuretic dosing regimen of the patient.As even another example and still referring to columns 902, 952, if thesensed LAP is lower than the baseline LAP by a threshold, whichcorresponds to rows 912, 962, then it is likely the intravascular volumeof the patient has decreased, and the corresponding treatment regimenindicated in table 950 is to decrease the diuretic dosing regimen of thepatient.

Referring to columns 904, 954, the sensed RAP is within a threshold ofthe baseline RAP. In the event the sensed LAP is higher than thebaseline LAP by a threshold, then it is likely the SVR of the patienthas increased and the intravascular volume of the patient has increased.In this case, the vasodilator dosing regimen of the patient isincreased, and the diuretic dosing regimen of the patient is increased.As another example and still referring to columns 904, 954, if thesensed LAP is within a threshold of the baseline LAP, then it is likelythe dosing regimen of the patient is effective, and the currenttreatment regimen is maintained. As even another example and stillreferring to columns 904, 954, if the sensed LAP is lower than thebaseline LAP by a threshold, then it is likely the patient's PVR hasincreased, or the patient's RHF is worsening and the intravascularvolume of the patient has decreased. In this case, the treatment regimenindicated in table 950 is to increase the pulmonary vasodilators dosingregimen and decrease the diuretic dosing regimen.

Referring to columns 906, 956, the sensed RAP is greater than thebaseline RAP by a threshold. In the event the sensed LAP is higher thanthe baseline LAP by a threshold, then it is likely the intravascularvolume of the patient has increased so the corresponding treatmentregimen indicated in table 950 is to increase the diuretic dosingregimen of the patient. As another example and still referring tocolumns 906, 956, if the sensed LAP is within a threshold of thebaseline LAP, then the patient's RHF is likely worsening and theintravascular volume of the patient has increased, or the patient's PVRhas increased and the intravascular volume of the patient has increased.In this case, the corresponding dosing regimen indicated in table 950 isto increase pulmonary vasodilators and increase diuretics. As evenanother example and still referring to columns 906, 956, if the sensedLAP is lower than the baseline LAP by a threshold, then it is likely thepatient's RHF is worsening. In this case, the corresponding treatmentregimen indicated in table 950 is to increase the pulmonaryvasodilators. For any of these dosing regimen changes, the monitoringsystem 72 may send a notification and/or send corresponding instructionsto a therapy device.

In some embodiments, the method 200 (and/or algorithm 99) mayincorporate additional metrics such as systemic blood pressure and heartrate to determine the addition of other medications beyond diuretics,vasodilators, and pulmonary vasodilators to address a rise in pressure.For example, an increase in heart rate may determine the need for anincrease in dosage of beta blockers instead of vasodilators in order toreduce a high LAP pressure. As another example, a very low bloodpressure combined with high LAP and high RAP may determine the need forinotropes instead of diuretics. Additionally, in at least someembodiment, the method 200 (and/or algorithm 99) may be used to indicatethe need for treatments beyond medications titrations includinglifestyle changes (diet, activity), advanced therapy (VADs, transplant),or therapeutic interventions (intra-atrial shunts, CRTs, ICDs, valverepair/replacement, ablations, etc.)

Persons skilled in the art will readily appreciate that various aspectsof the present disclosure can be realized by any number of methods andapparatus configured to perform the intended functions. It should alsobe noted that the accompanying drawing figures referred to herein arenot necessarily drawn to scale but may be exaggerated to illustratevarious aspects of the present disclosure, and in that regard, thedrawing figures should not be construed as limiting.

The invention of this application has been described above bothgenerically and with regard to specific embodiments. It will be apparentto those skilled in the art that various modifications and variationscan be made in the embodiments without departing from the scope of thedisclosure. Thus, it is intended that the embodiments cover themodifications and variations of this invention provided they come withinthe scope of the appended claims and their equivalents.

What is claimed is:
 1. A medical system for determining a treatmentregimen for a patient with a condition, the system comprising: at leastone sensor configured to sense right atrial pressure and left atrialpressure; and a receiver configured to receive measurement datacorresponding to the sensed right atrial pressure and the sensed leftatrial pressure, and output to a display device the received measurementdata, wherein the condition is at least one selected from the group of:left heart failure, right heart failure, and primary pulmonary disorder.2. The medical system of claim 1, further comprising: a memory unitconfigured to store the received measurement data and the condition ofthe patient; and a processor configured to determine, based on thereceived measurement data and the condition of the patient, thetreatment regimen for the patient.
 3. The medical system of claim 2,wherein to determine the treatment regimen of the patient, the processoris configured to: compare the sensed right atrial pressure to a baselineright atrial pressure; and compare the sensed left atrial pressure to abaseline left atrial pressure.
 4. The medical system of claim 2, whereinto determine the treatment regimen of the patient, the processor isconfigured to: compare the sensed right atrial pressure and the sensedleft atrial pressure.
 5. The medical system of claim 2, wherein todetermine the treatment regimen for the patient, the processor isconfigured to provide a notification to increase the dosage of thetreatment regimen.
 6. The medical system of claim 2, wherein todetermine the treatment regimen for the patient, the processor isconfigured to provide a notification to decrease the dosage of thetreatment regimen.
 7. The medical system of claim 2, wherein theprocessor is incorporated into an implantable medical device.
 8. Themedical system of claim 2, wherein the processor is incorporated into adevice located external to the patient.
 9. The medical system of claim2, wherein to determine the treatment regimen of the patient, theprocessor is configured to provide a notification to increase at leastone treatment selected from the following group of treatments:vasodilators, diuretics, pulmonary vasodilators, neurohormonalantagonists, beta blockers, and inotropes.
 10. The medical system ofclaim 2, wherein to determine the treatment regimen of the patient, theprocessor is configured to provide a notification to decrease at leastone treatment selected from the following group of treatments:vasodilators, diuretics pulmonary vasodilators, neurohormonalantagonists, beta blockers, and inotropes.
 11. A computer-implementedmethod for determining a treatment regimen for a patient with acondition, the method comprising: receiving at least one measurementcorresponding to a sensed right atrial pressure for the patient;receiving at least one measurement corresponding to a sensed left atrialpressure for the patient; and outputting to a display device: the atleast one measurement corresponding to the sensed right atrial pressure,the at least one measurement corresponding to the sensed left atrialpressure, wherein the condition is at least one selected from the groupof: left heart failure, right heart failure, and primary pulmonarydisorder.
 12. The method of claim 11, further comprising determining thetreatment regimen for the patient based on: the at least one measurementcorresponding to the sensed right atrial pressure, the at least onemeasurement corresponding to the sensed left atrial pressure, and thecondition of the patient.
 13. The method of claim 12, whereindetermining the treatment regimen of the patient comprises: comparingthe sensed right atrial pressure to a baseline right atrial pressure;and comparing the sensed left atrial pressure to a baseline left atrialpressure.
 14. The method of claim 11, wherein determining the treatmentregimen of the patient comprises comparing the sensed right atrialpressure and the sensed left atrial pressure.
 15. The method of claim12, wherein determining the treatment regimen for the patient comprisesproviding a notification to increase the dosage of the treatmentregimen.
 16. The method of claim 12, wherein determining the treatmentregimen for the patient comprises providing a notification to decreasethe dosage of the treatment regimen.
 17. The method of claim 12, whereindetermining the treatment regimen of the patient comprises providing anotification to increase at least one treatment selected from thefollowing group of treatments: vasodilators, diuretics, pulmonaryvasodilators, neurohormonal antagonists, beta blockers, and inotropes.18. The method of claim 12, wherein determining the treatment regimen ofthe patient comprises providing a notification to decrease at least onetreatment selected from the following group of treatments: vasodilators,diuretics, and pulmonary vasodilators, neurohormonal antagonists, betablockers, and inotropes.
 19. A monitoring system, comprising: a receiverconfigured to receive measurements associated with the left heartpressure and the right heart pressure; a memory unit configured to storethe received measurements; a display device; and a processing deviceconfigured to: compare the measurements associated with the left heartpressure and the measurements associated with the right heart pressure;and output, to the display device, the comparison.
 20. The monitoringsystem of claim 19, wherein the processing device is further configuredto determine, based on the comparison, a treatment regimen for thepatient.
 21. The monitoring system of claim 19, wherein the measurementsassociated with the left heart pressure are left atrial pressuremeasurements.
 22. The monitoring system of claim 19, wherein themeasurements associated with the left heart pressure are surrogates forthe left heart pressure, wherein the surrogates are at least onesurrogate selected from the following group of surrogates: pulmonaryartery pressure (PAP), pulmonary arterial wedge pressure (PAWP),pulmonary artery systolic pressure (PASP), pulmonary artery diastolicpressure (PADP), right ventricular systolic pressure (RVSP), estimatedpulmonary artery diastolic pressure (ePAD), and left ventricularend-diastolic pressure (LVEDP).
 23. The monitoring system of claim 19,wherein the measurements associated with the right heart pressure areright atrial pressure measurements.
 24. The monitoring system of claim19, wherein the measurements associated with the right heart pressureare surrogates for the right heart pressure, wherein the surrogates areat least one surrogate selected from the following group of surrogates:right ventricular end-diastolic pressure (RVEDP), central venouspressure (CVP), and jugular venous pulse (JVP).
 25. The monitoringsystem of claim 20, wherein the treatment comprises at least treatmentselected from the following group of treatments: diagnosis, medicationtitrations, advanced therapy, IV medications, lifestyle changes,intra-atrial shunts, valve repair/replace, ICDs, CRTs, and ablation. 26.The monitoring system of claim 25, wherein the medication titrationscomprise at least one titration selected from the following group oftitrations: vasodilators, diuretics, pulmonary vasodilators,neurohormonal antagonists, beta blockers, and inotropes.
 27. Themonitoring system of claim 25, wherein the advanced therapy comprisesone or more selected from the group of: implanting a ventricular assistdevice (VAD), implanting a mechanical circulator support (MCS), atransplant, or both.
 28. The monitoring system of claim 25, wherein thelifestyle changes comprise at least one lifestyle change selected fromthe following group of lifestyle changes: a change in diet, increasedactivity, or both.
 29. The monitoring system of claim 19, furthercomprising a sensor configured to sense the measurements associated withthe left heart pressure and the right heart pressure.
 30. The monitoringsystem of claim 19, wherein the processing device is further configuredto output the determined treatment to a display device.
 31. Themonitoring system of claim 19, wherein the processing device is furtherconfigured to diagnose, based on the comparison, the patient.
 32. Themonitoring system of claim 19, wherein the monitoring system is a closedloop system where trend data of the measurements inform changes to anautomated dispensing of a medicine.
 33. The monitoring system of claim32, wherein the medicine is a diuretic, vasodilator, or both.
 34. Themonitoring system of claim 19, wherein the monitoring system is a closedloop system where trend data of the measurements inform changes to aventricular assist device.
 35. The monitoring system of claim 19,wherein the monitoring system is used to determine RPM changes in aventricular assist device.
 36. The monitoring system of claim 20,wherein the processing device uses machine learning to modify thetreatment regimen.
 37. The monitoring system of claim 20, wherein theprocessing device is further configured to output to the display deviceone or more of the following: left atrial pressure, left atrial pressureaverages, right atrial pressure, right atrial pressure averages, trendarrows of the measurements, line graphs over time of the measurements,waveforms of the measurements, and one or more medications of a patientassociated with the measurements.
 38. A medical system for determining atreatment regimen, the system comprising: at least one sensor configuredto sense right atrial pressure and left atrial pressure; and a receiverconfigured to receive a condition of the patient and measurement datacorresponding to the sensed right atrial pressure and the sensed leftatrial pressure, wherein the condition is at least one selected from thegroup of: left heart failure, right heart failure, and primary pulmonarydisorder; a memory unit configured to store the received measurementdata and the condition of the patient; and a processor configured todetermine, based on the received measurement data and the condition ofthe patient, the treatment regimen for the patient.